ABSORB III Randomized Controlled Trial (RCT)

Coronary Artery Disease Clinical Trial

— ABSORB-III  

Official title:

A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751906
• Other study ID #: 10-392
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: October 2020

Study information

• Verified date: January 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

Description:

ABSORB III RCT:

A. Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

B. Powered Secondary Objectives:

1. Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice.

The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III.

The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm.

2. Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement.

All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2008
• Est. completion date: October 2020
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

General Inclusion Criteria:

1. Subject must be at least 18 years of age.

2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.

3. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.

4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

5. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.

6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.

7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

Angiographic Inclusion Criteria:

1. One or two de novo target lesions:

1. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.

2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.

3. The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.

2. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of = 50% and < 100% with a TIMI flow of = 1 and one of the following: stenosis = 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.

1. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of = 2.50 mm and = 3.75 mm.

2. Lesion(s) must be located in a native coronary artery with length by visual estimation of = 24 mm.

3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a native coronary artery with RVD by visual estimation of = 2.75 mm and = 3.25 mm. The lesion length by visual estimation is = 8 mm and = 14 mm.

General Exclusion Criteria:

1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.

2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.

3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.

4. Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.

5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

6. Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:

1. Subject requires coumadin or any other agent for chronic oral anticoagulation.

2. Subject is likely to become hemodynamically unstable due to their arrhythmia.

3. Subject has poor survival prognosis due to their arrhythmia.

7. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, Multiple-Gated Acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with ACS, LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.

8. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.

9. Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure

10. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.

11. At the time of screening, the subject has a malignancy that is not in remission.

12. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.

13. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.

14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).

15. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.

16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh = Class B.

17. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or dialysis at the time of screening.

18. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.

19. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.).

20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.

21. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.

22. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.

23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

24. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

1. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

1. Residual %DS is a maximum < 40% (per visual estimation), = 20% is strongly recommended.

2. TIMI Grade-3 flow (per visual estimation).

3. No angiographic complications (e.g. distal embolization, side branch closure).

4. No dissections NHLBI grade D-F.

5. No chest pain lasting > 5 minutes.

6. No ST depression or elevation lasting > 5 minutes.

2. Lesion is located in left main.

3. Aorto-ostial RCA lesion (within 3 mm of the ostium).

4. Lesion located within 3 mm of the origin of the LAD or LCX.

5. Lesion involving a bifurcation with a:

1. side branch = 2 mm in diameter, or

2. side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or

3. side branch requiring dilatation

6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:

1. Extreme angulation (= 90°) proximal to or within the target lesion.

2. Excessive tortuosity (= two 45° angles) proximal to or within the target lesion.

3. Moderate or heavy calcification proximal to or within the target lesion. If IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is = 180°.

7. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.

8. Lesion or vessel involves a myocardial bridge.

9. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.

10. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.

11. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Device:
• Absorb BVS
Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length = 24 mm) with a reference vessel diameter of = 2.5 mm and = 3.75 mm.
• XIENCE
Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length = 24 mm) with a reference vessel diameter of = 2.5 mm and = 3.75 mm.

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Presbyterian Hospital	Albuquerque	New Mexico
United States	Northwest Texas Healthcare System	Amarillo	Texas
United States	AnMed Health	Anderson	South Carolina
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	University Hospital	Augusta	Georgia
United States	Seton Medical Center Austin	Austin	Texas
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Bay Regional Medical Center	Bay City	Michigan
United States	St. Joseph Hospital	Bellingham	Washington
United States	Baptist Medical Center Princeton	Birmingham	Alabama
United States	University of Alabama Hospital	Birmingham	Alabama
United States	Boston University Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Brandon Regional Hospital	Brandon	Florida
United States	St. Elizabeth's Medical Center of Boston	Brighton	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Holy Spirit Hospital	Camp Hill	Pennsylvania
United States	Aultman Hospital	Canton	Ohio
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Memorial Hospital	Chattanooga	Tennessee
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	The Christ Hospital	Cincinnati	Ohio
United States	Tri-Health Good Samaritan Hospital	Cincinnati	Ohio
United States	University Hospital	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	UCH-Memorial Health Systems	Colorado Springs	Colorado
United States	Boone Hospital Center	Columbia	Missouri
United States	Sisters of Charity Providence Hospital	Columbia	South Carolina
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	John Muir Medical Center - Concord Campus	Concord	California
United States	Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Genesis Medical Center	Davenport	Iowa
United States	Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Harper University Hospital	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	St. John Hospital & Medical Center	Detroit	Michigan
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	Elkhart General Healthcare	Elkhart	Indiana
United States	EMH Healthcare	Elyria	Ohio
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	UPMC Hamot	Erie	Pennsylvania
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Thomas Hospital	Fairhope	Alabama
United States	Cleveland Cln Fairview Hospital	Fairview Park	Ohio
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Medical Center of the Rockies	Fort Collins	Colorado
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Mary Washington Hospital	Fredericksburg	Virginia
United States	Washington Hospital	Fremont	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Chandler Regional Medical Center	Gilbert	Arizona
United States	Greenville Memorial Hospital of the Greenville Health System	Greenville	South Carolina
United States	St. Francis Health System	Greenville	South Carolina
United States	Cooper University Hospital	Haddon Heights	New Jersey
United States	Our Lady of Lourdes Medical Center	Haddon Heights	New Jersey
United States	Memorial Regional Hospital	Hollywood	Florida
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	MedStar Washington Hospital Center	Hyattsville	Maryland
United States	Union Memorial Hospital	Hyattsville	Maryland
United States	Franciscan St. Francis Health	Indianapolis	Indiana
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Baptist Medical Center - Downtown	Jacksonville	Florida
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	University of Florida UF Health	Jacksonville	Florida
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	The University of Kansas Hospital and Medical Center	Kansas City	Kansas
United States	Kettering Medical Center	Kettering	Ohio
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Turkey Creek Medical Center	Knoxville	Tennessee
United States	Scripps Green Hospital	La Jolla	California
United States	Scripps Memorial Hospital	La Jolla	California
United States	St. Mary Medical Center	Langhorne	Pennsylvania
United States	Sparrow Hospital	Lansing	Michigan
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Baptist Health Lexington	Lexington	Kentucky
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Nebraska Heart Hospital	Lincoln	Nebraska
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	St. Joseph's Hospital Health Center	Liverpool	New York
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Good Samaritan Hospital	Los Angeles	California
United States	Jewish Hospital	Louisville	Kentucky
United States	Long Island Jewish Medical Center	Manhasset	New York
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	Banner Heart Hospital	Mesa	Arizona
United States	Baptist Hospital of Miami	Miami	Florida
United States	University of Miami Hospital	Miami	Florida
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	St. Patrick Hospital	Missoula	Montana
United States	Sutter Central Valley Hospitals dba Memorial Medical Center	Modesto	California
United States	Baptist Medical Center South	Montgomery	Alabama
United States	Morristown Medical Center	Morristown	New Jersey
United States	InterMountain Medical Center	Murray	Utah
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Lennox Hill Hospital,	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	New York Presbyterian Hospital-Cornell University	New York	New York
United States	Christiana Care Health Services	Newark	Delaware
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	MediQuest Research Group Inc at Munroe Regional Medical Center	Ocala	Florida
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Palm Beach Gardens Medical Center	Palm Beach Gardens	Florida
United States	Bay County Health Systems	Panama City	Florida
United States	St. Joseph's Regional Medical Center	Paterson	New Jersey
United States	Baptist Hospital	Pensacola	Florida
United States	Saint Francis Medical Center	Peoria	Illinois
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	UPMC Shadyside Hospital	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Maine Medical Center	Portland	Maine
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island
United States	Rex Hospital	Raleigh	North Carolina
United States	WakeMed	Raleigh	North Carolina
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	North Memorial Medical Center	Robbinsdale	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	Strong Memorial Hospital	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	Sutter Medical Center	Sacramento	California
United States	UC Davis Medical Center	Sacramento	California
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	St. Anthony's Medical Center	Saint Louis	Missouri
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	Methodist Texsan Hospital	San Antonio	Texas
United States	Sharp Memorial Hospital	San Diego	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Swedish Medical Center	Seattle	Washington
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	PeaceHealth Sacred Heart Medical Center	Springfield	Oregon
United States	St. John's Hospital	Springfield	Illinois
United States	St. Vincent's Medical Center	Stamford	Connecticut
United States	Stanford Hospital and Clinics	Stanford	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Florida Hospital Pepin Heart Institute	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	Mercy St. Vincent's Medical Center	Toledo	Ohio
United States	The Toledo Hospital	Toledo	Ohio
United States	Little Company Of Mary Hospital	Torrance	California
United States	Torrance Memorial Medical Center	Torrance	California
United States	Munson Medical Center	Traverse City	Michigan
United States	Hillcrest Medical Center	Tulsa	Oklahoma
United States	North Mississippi Medical Center Cardiology Associates Research, LLC	Tupelo	Mississippi
United States	East Texas Medical Center	Tyler	Texas
United States	Trinity Mother Frances Hospital Regional Healthcare Center	Tyler	Texas
United States	Mercy Medical	West Des Moines	Iowa
United States	Winchester Medical Center	Winchester	Virginia
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	Pinnacle Health at Harrisburg Hospital	Wormleysburg	Pennsylvania
United States	St. Joseph Medical Center	Wyomissing	Pennsylvania
United States	York Hospital	York	Pennsylvania
United States	St. Joseph Mercy Hospital	Ypsilanti	Michigan
United States	Genesis-Good Samaritan Hospital	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Reported Outcomes (PRO): Overall Health Status	Overall health status assessed using the EuroQoL 5D (EQ-5D™).; EQ-5D: Scale range: 0 to 1; Higher values represent better outcomes; Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.; A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1	Baseline
Other	Patient Reported Outcomes (PRO): Overall Health Status	Overall health status assessed using the EuroQoL 5D (EQ-5D™).; EQ-5D: Scale range: 0 to 1; Higher values represent better outcomes; Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.; A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1	1 month
Other	Patient Reported Outcomes (PRO): Overall Health Status	Overall health status assessed using the EuroQoL 5D (EQ-5D™).; EQ-5D: Scale range: 0 to 1; Higher values represent better outcomes; Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.; A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1	12 months
Other	Patient Reported Outcomes (PRO): Anxiety	Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).; GAD-7: Scale range: 0 to 21; Lower values represent better outcomes; No subscales	Baseline
Other	Patient Reported Outcomes (PRO): Anxiety	Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).; GAD-7: Scale range: 0 to 21; Lower values represent better outcomes; No subscales	1 month
Other	Patient Reported Outcomes (PRO): Anxiety	Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).; GAD-7: Scale range: 0 to 21; Lower values represent better outcomes; No subscales	12 months
Other	Patient Reported Outcomes (PRO): Disease-Specific Quality of Life	Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ); Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).	Baseline
Other	Patient Reported Outcomes (PRO): Disease-Specific Quality of Life	Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).; Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).	1 month
Other	Patient Reported Outcomes (PRO): Disease-Specific Quality of Life	Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).; Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).	12 months
Other	Patient Reported Outcomes (PRO): Dyspnea Severity	Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).; Rose Dyspnea Scale: Scale range: 0 to 4; Lower values represent better outcomes (higher scores indicate worse dyspnea); No subscales	Baseline
Other	Patient Reported Outcomes (PRO): Dyspnea Severity	Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).; Rose Dyspnea Scale: Scale range: 0 to 4; Lower values represent better outcomes (higher scores indicate worse dyspnea); No subscales	1 month
Other	Patient Reported Outcomes (PRO): Dyspnea Severity	Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).; Rose Dyspnea Scale: Scale range: 0 to 4; Lower values represent better outcomes (higher scores indicate worse dyspnea); No subscales	12 months
Other	Landmark Analysis on TLF and Components	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	3-4 years
Other	Landmark Analysis on TLF and Components	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	3-5 years
Other	Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.; Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of; Any unexplained death within the first 30 days or; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	3-4 years
Other	Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.; Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of; Any unexplained death within the first 30 days or; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	3-5 years
Primary	Number of Cardiac Death/TV-MI/ID-TLR (TLF)	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	1 year
Secondary	Number of Participants With Powered Secondary Endpoint: Angina	Angina is defined as the first adverse event resulting in the site diagnosis of angina.	1 year
Secondary	Number of Participants With Powered Secondary Endpoint: All Revascularization	This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.	1 year
Secondary	Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)	This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.	1 year
Secondary	Acute Success- Device Success (Lesion Level Analysis)	Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.	On day 0 (the day of procedure)
Secondary	Acute Success: Procedural Success (Subject Level Analysis)	Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).	On day 0 (the day of procedure)
Secondary	Number of Death (Cardiac, Vascular, Non-cardiovascular)	DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.; Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	0 to 5 years
Secondary	Number of Participants With All Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	0 to 5 years
Secondary	Number of Participants With All Target Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.; The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.	0 to 5 years
Secondary	Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.	0 to 5 years
Secondary	Number of Participants With All Revascularization	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.	0 to 5 years
Secondary	Number of Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 5 years
Secondary	Number of Cardiac Death/All MI	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.; Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.; -Non-Q wave MI: Those MIs which are not Q-wave MI	0 to 5 years
Secondary	Number of Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	0 to 5 years
Secondary	Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	0 to 5 years
Secondary	Number of Participants With Target Vessel Failure (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	0 to 5 years
Secondary	Number of Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	0 to 5 years
Secondary	Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.; Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	= 1 Day
Secondary	Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.; Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	0 to 30 Days
Secondary	Number of Participants With Subacute Stent/Scaffold Thrombosis	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.; Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	>1 to 30 Days
Secondary	Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.; Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of; Any unexplained death within the first 30 days or; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	31 to 365 Days
Secondary	Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.; Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of; Any unexplained death within the first 30 days or; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	366 to 393 Days
Secondary	Number of Participants With Cumulative Stent/Scaffold Thrombosis	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.; Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of; Any unexplained death within the first 30 days or; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	0 to 1853 Days
Secondary	Pre-Procedure Minimum Lumen Diameter (MLD)	Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.	< or = 1 day
Secondary	Pre-Procedure Percent Diameter Stenosis (%DS)	Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).	< or = 1 day
Secondary	Post-Procedure In-Segment Minimum Lumen Diameter (MLD)	Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.; In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.	= 7 days post index procedure
Secondary	Post-Procedure In-Segment Percent Diameter Stenosis (%DS)	Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).; In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.	= 7 days post index procedure
Secondary	Post-Procedure In-Device Minimum Lumen Diameter (MLD)	Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.; In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold	= 7 days post index procedure
Secondary	Post-Procedure In-Device Percent Diameter Stenosis (%DS)	Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).	= 7 days post index procedure
Secondary	Post-Procedure In-Device Acute Gain	The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).	= 7 days post index procedure
Secondary	Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)	Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects.; Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.	From Post procedure to 3 Years
Secondary	Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions	3 Years
Secondary	Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions	3 Years
Secondary	Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions	3 Years
Secondary	Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions	3 Years
Secondary	Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions	3 Years