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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00180479
Other study ID # 03-360
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated November 16, 2011
Start date June 2005
Est. completion date November 2011

Study information

Verified date November 2011
Source Abbott Vascular
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is divided into 5 arms:

1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System

2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS

3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS

4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS

5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan

The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.


Description:

The purpose of the SPIRIT III clinical trial is to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS). The XIENCE V® EECS (XIENCE V® arm) will be compared to an active control group represented by the FDA approved commercially available Boston Scientific TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System (TAXUS® arm).

The SPIRIT III clinical trial consists of a randomized clinical trial (RCT) in the US which will enroll approximately 1,002 subjects (2:1 randomization XIENCE V® EECS : TAXUS® EXPRESS2™ PECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and <= 3.75 mm.

The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms (2.25 mm diameter stent, 4.0 mm diameter stent and 38 mm length stent arms) and one Japanese non-randomized arm as follows:

1. 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 2.25 mm and < 2.5 mm and lesion length <= 22 mm will be enrolled concurrently in the US 2.25 mm non-randomized treatment arm

2. 80 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.75 mm and >= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the US 4.0 mm non-randomized treatment arm

3. 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.0 mm and < 4.25 mm and lesion length > 24 mm and < 32 mm will be enrolled concurrently in the US 38 mm non-randomized treatment arm.

4. 88 Japanese subjects with a maximum of two de novo native coronary artery lesions within vessel sizes >= 2.5 mm and <= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the non-randomized Japanese arm.

All subjects in the RCT and the four non-randomized arms will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the TAXUS® arm of US RCT.

Subjects enrolled in the US RCT will be sub-grouped based on whether they will have an angiographic and/or an intravascular ultrasound (IVUS) follow-up at 240 days as follows:

Group A: Angiographic and IVUS follow-up at 240 days (N=240) Group B: Angiographic follow-up at 240 days (N=324) Group C: No angiographic or IVUS follow-up (N=438)

All subjects will have clinical follow-up at 30, 180, 240 and 270 days (Data collected through 270 days will be submitted as the primary data set for US and Japanese market approval), and 1, 2, 3, 4, and 5 years (for annual reports).

All subjects enrolled into three US non-randomized arms (N=105 for 2.25 mm arm, N=80 for 4.0 mm arm and N=105 for 38 mm stent arm) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic follow-up at 240 days. No IVUS follow-up is required for subjects enrolled in these arms.

All subjects enrolled into the Japanese non-randomized arm (N=88) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic and IVUS follow-up at 240 days.

All subjects who receive a bailout stent will be assigned to Group A follow-up subgroup (angiographic and IVUS follow-up at 240 days after the index procedure), regardless of their primary assignment at randomization. At sites without IVUS capability, subjects receiving bailout stent will be assigned to Group B follow-up subgroup (angiographic follow-up at 240 days after the index procedure). Angiographic follow-up is required for all bailout subjects at 240 days.

Data from the US RCT will be submitted to the FDA as the primary data set for product approval for RVD >= 2.5 mm and <= 3.75 mm (2.5 mm, 3.0 mm and 3.5 mm stents). Combined data of the US trial/Japanese non-randomized arm will be submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Japanese approval for RVD>=2.5 mm and <= 4.25 mm (2.5 mm, 3.0 mm 3.5 mm and 4.0 mm stents). Data from the Japanese non-randomized arm will be submitted to the FDA as additional safety data. Data from the US non-randomized arms of the trial will be the primary data sets for approval for 2.25 mm diameter stent (RVD > 2.25 mm and < 2.5 mm), 4.0 mm diameter stent (RVD > 3.75 mm and <= 4.25 mm) and 38 mm length stent (RVD > 3.0 mm and <= 4.25 mm and lesion length > 24 mm and <= 32 mm), respectively in the US.

A pharmacokinetic substudy will be carried out in a minimum of 5 pre-determined sites in the US and a minimum of 5 pre-determined sites in Japan. In the US, the pharmacokinetics (PK) of everolimus, as delivered by the XIENCE V® EECS will be analyzed in a subset of 15 subjects (minimum) with single vessel/lesion treatment, and up to 20 subjects with dual vessel/lesion treatment, respectively. In Japan, a minimum of 10 subjects with single vessel/lesion treatment and up to 20 subjects with dual vessel/lesion treatment will have a PK measurements performed. These subsets will include subjects receiving overlapping stents.


Recruitment information / eligibility

Status Completed
Enrollment 1002
Est. completion date November 2011
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and <= 4.25 mm and a lesion length <= 32 mm

- The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of >= 1

- Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)

Exclusion Criteria:

- Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft

- Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation

- Located in a major epicardial vessel that has been previously treated with brachytherapy

- Located in a major epicardial vessel that has been previously treated with percutaneous intervention < 9 months prior to index procedure

- Total occlusion (TIMI flow 0), prior to wire passing

- The target vessel contains thrombus

- Another significant lesion (> 40% diameter stenosis [DS]) is located in the same epicardial vessel as the target lesion

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Device:
XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.

Locations

Country Name City State
United States Presbyterian Hospital Albuquerque New Mexico
United States Emory Crawford Long Hospital Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Saint Joseph's Hospital of Atlanta Atlanta Georgia
United States Heart Hospital of Austin Austin Texas
United States Johns Hopkins Hospital Baltimore Maryland
United States Baptist Health System - Montclair Birmingham Alabama
United States Baptist Medical Center Princeton Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham & Women's Hospital Boston Massachusetts
United States Fletcher Allen Health Care Burlington Vermont
United States Medical University of South Carolina Charleston South Carolina
United States Presbyterian Hospital Charlotte North Carolina
United States Rush University Medical Center Chicago Illinois
United States The Christ Hospital Cincinnati Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States Medical City Dallas Hospital Dallas Texas
United States St John Hospital & Medical Center Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States EMH Regional Medical Center Elyria Ohio
United States Sacred Heart Medical Center Eugene Oregon
United States Poudre Valley Hospital Fort Collins Colorado
United States Holy Cross Medical Center (prev. North Ridge MC) Fort Lauderdale Florida
United States Spectrum Health Hospital Grand Rapids Michigan
United States Hackensack Medical Center Hackensack New Jersey
United States Pinnacle Health @ Harrisburg Hospital Harrisburg Pennsylvania
United States Methodist Hospital Houston Texas
United States The Heart Center of IN, LLC Indianapolis Indiana
United States Borgess Medical Center Kalamazoo Michigan
United States St. Luke's Hospital Kansas City Missouri
United States Scripps Memorial Hospital La Jolla California
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Nebraska Heart Hospital Lincoln Nebraska
United States Good Samaritan Hospital Los Angeles California
United States Jewish Hospital Louisville Kentucky
United States Baptist Hospital of Miami Miami Florida
United States St. Luke's Medical Center Milwaukee Wisconsin
United States Abbott Northwestern Hospital Minneapolis Minnesota
United States St. Patrick Hospital Missoula Montana
United States Long Island Jewish Medical Center New Hyde Park New York
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Columbia University Medical Center New York New York
United States Alta Bates Summit Medical Center Oakland California
United States Integris Baptist Medical, Inc. Oklahoma City Oklahoma
United States The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Northern Michigan Hospital Petoskey Michigan
United States Arizona Heart Hospital Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
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 Wake Medical Center Raleigh North Carolina
United States The Valley Hospital Ridgewood New Jersey
United States Mercy General Hospital Sacramento California
United States TexSan Heart Hospital San Antonio Texas
United States Swedish Medical Center Seattle Washington
United States St. John's Hospital Springfield Illinois
United States Barnes Jewish Hospital St. Louis Missouri
United States St. Joseph's Hospital Health Center Syracuse New York
United States Washington Adventist Hospital Takoma Park Maryland
United States St. Joseph Medical Center Towson Maryland
United States North Mississippi Medical Center Tupelo Mississippi
United States Washington Hospital Center Washington District of Columbia
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

References & Publications (3)

Lansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results — View Citation

Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Caputo R, Xenopoulos N, Applegate R, Gordon P, White RM, Sudhir K, Cutlip DE, Petersen JL; SPIRIT III Investigators. Randomized comparison of everolimus-eluting and paclitaxel-elutin — View Citation

Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with co — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Endpoint: In-segment Late Loss (LL) In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment. 240 days Yes
Secondary Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
270 days Yes
Secondary Target Vessel Failure (TVF) The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
30 days Yes
Secondary Target Vessel Failure (TVF) The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
180 days No
Secondary Target Vessel Failure (TVF) The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
1 year No
Secondary Target Vessel Failure (TVF) The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
2 year No
Secondary Target Vessel Failure (TVF) The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
3 year Yes
Secondary Target Vessel Failure (TVF) The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
4 year Yes
Secondary Ischemia Driven Target Lesion Revascularization (ID-TLR) Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis =50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis =70% by core laboratory QCA without angina or (+) functional study
30 days No
Secondary Ischemia Driven Target Lesion Revascularization (ID-TLR) Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis =50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis =70% by core laboratory QCA without angina or (+) functional study
180 days No
Secondary Ischemia Driven Target Lesion Revascularization (ID-TLR) Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis =50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis =70% by core laboratory QCA without angina or (+) functional study
270 days No
Secondary Ischemia Driven Target Lesion Revascularization (ID-TLR) Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis =50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis =70% by core laboratory QCA without angina or (+) functional study
1 years No
Secondary Ischemia Driven Target Lesion Revascularization (ID-TLR) Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis =50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis =70% by core laboratory QCA without angina or (+) functional study
2 years No
Secondary Ischemia Driven Target Lesion Revascularization (ID-TLR) Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis =50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis =70% by core laboratory QCA without angina or (+) functional study
3 year No
Secondary Ischemia Driven Target Lesion Revascularization (ID-TLR) Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis =50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis =70% by core laboratory QCA without angina or (+) functional study
4 year No
Secondary Ischemia Driven Target Vessel Revascularization (ID-TVR) Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis = 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis = 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
30 days No
Secondary Ischemia Driven Target Vessel Revascularization (ID-TVR) Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis = 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis = 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
180 days No
Secondary Ischemia Driven Target Vessel Revascularization (ID-TVR) Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis = 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis = 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
270 days Yes
Secondary Ischemia Driven Target Vessel Revascularization (ID-TVR) Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis = 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis = 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
1 year No
Secondary Ischemia Driven Target Vessel Revascularization (ID-TVR) Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis = 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis = 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
2 years No
Secondary Ischemia Driven Target Vessel Revascularization (ID-TVR) Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis = 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis = 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
3 years No
Secondary Ischemia Driven Target Vessel Revascularization (ID-TVR) Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis = 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis = 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
4 years No
Secondary Ischemia Driven Major Adverse Cardiac Event (MACE) The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
30 days Yes
Secondary Ischemia Driven Major Adverse Cardiac Event (MACE) The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
180 days Yes
Secondary Ischemia Driven Major Adverse Cardiac Event (MACE) The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
270 days Yes
Secondary Ischemia Driven Major Adverse Cardiac Event (MACE) The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
1 year Yes
Secondary Ischemia Driven Major Adverse Cardiac Event(MACE) The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
2 years Yes
Secondary Ischemia Driven Major Adverse Cardiac Event (MACE) The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
3 year Yes
Secondary Ischemia Driven Major Adverse Cardiac Event (MACE) The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
4 year Yes
Secondary In-stent % Angiographic Binary Restenosis (% ABR) Rate Percent of subjects with a follow-up in-stent percent diameter stenosis of = 50% per quantitative coronary angiography (QCA) at 240 days No
Secondary In-segment % Angiographic Binary Restenosis (% ABR) Rate Percent of subjects with a follow-up in-segment percent diameter stenosis of = 50% per QCA 240 days No
Secondary Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection Incomplete Apposition (Persisting & Late acquired): Failure to completely appose vessel wall w/ =1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion = 1.5 of reference vessel diameter. Thrombus: Protocol & ARC definition.
Persisting dissection @ follow-up, present post-procedure.
at 240 days No
Secondary Acute Success: Clinical Device Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%. In-hospital Yes
Secondary Acute Success: Clinical Procedure Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%. In-hospital No
Secondary Proximal Late Loss Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement) at 240 days No
Secondary Distal Late Loss Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement) 240 days No
Secondary In-stent Late Loss In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent) at 240 days No
Secondary % Volume Obstruction (% VO) Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS. at 240 days No
Secondary In-stent % Diameter Stenosis (% DS) In-stent: Within the margins of the stent, the value calculated as 100 * (1 - in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. at 240 days No
Secondary In-segment % Diameter Stenosis (% DS) Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 * (1 - in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. 240 days No
Secondary Target Vessel Failure (TVF) The composite endpoint comprised of:
Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
5 years Yes
Secondary Ischemia Driven Target Lesion Revascularization (ID-TLR) Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis =50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis =70% by core laboratory QCA without angina or (+) functional study
5 years No
Secondary Ischemia Driven Target Vessel Revascularization (ID-TVR) Revascularization at the target vessel associated with any of the following
Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis = 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis = 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
5 years No
Secondary Ischemia Driven Major Adverse Cardiac Event (MACE) The composite endpoint comprised of:
Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
5 years Yes
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