SPIRIT PRIME Clinical Trial

Coronary Artery Disease Clinical Trial

— SPIRIT PRIME  

Official title:

SPIRIT PRIME Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916370
• Other study ID #: 06-373
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2009
• Last updated: May 12, 2015
• Start date: June 2009
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: February 2014
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).

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

5. Subject must agree to undergo all protocol-required follow-up procedures.

6. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

1. One or two de novo target lesions each in a different epicardial vessel.

2. If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry.

o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed.

3. The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of = 50% and < 100% with a TIMI flow of = 1.

4. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of:

• = 2.25 mm and = 4.25 mm for treatment by the core size XIENCE PRIME EECS

• = 2.5 mm and = 4.25 mm for treatment by the XIENCE PRIME LL EECS

5. Target lesion(s) must be located in a native coronary artery with length by visual estimation of:

• = 22 mm for treatment by the core size XIENCE PRIME EECS

• > 22 mm and = 32 mm for treatment by the XIENCE PRIME LL EECS

Exclusion Criteria:

1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB = 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.

2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.

4. Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).

5. Subject has received coronary brachytherapy in any epicardial vessel (target or non target).

6. Subject has received any organ transplant or is on a waiting list for any organ transplant.

7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.

8. Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.

9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).

10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).

11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.

12. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.

13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.

14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).

15. Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level = 2.5 mg/dL, or on dialysis).

16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.

17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.

18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.

19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.

20. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).

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

22. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

1. Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.

2. Target lesion involving a bifurcation with a side branch = 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side branch requiring dilatation.

3. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.

4. Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.

5. Restenotic target lesion.

6. Aorto-ostial target lesion (within 3 mm of the aorta junction).

7. Target lesion is in a left main location.

8. Target lesion located within 2 mm of the origin of the LAD or LCX.

9. Extreme angulation (= 90 °) or excessive tortuosity (= two 45° angles) proximal to or within the lesion.

10. Heavy calcification proximal to or within the target lesion.

11. Target vessel contains thrombus as indicated in the angiographic images.

12. Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon).

13. Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.

14. Non-target vessel is previously treated with any type of PCI < 90 days prior to the index procedure.

15. Additional clinically significant lesion(s) (e.g. %DS = 50%) in a target vessel or side branch for which PCI may be required < 90 days after the index procedure.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Device:
• Core size Xience Prime
Core size includes a range of stent sizes.
• Xience Prime Long Lesion (LL)
Long lesion stent sizes include a range of sizes.

Locations

Country	Name	City	State
Australia	Wesley Hospital	Auchenflower	Queensland
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Monash Heart	Clayton	Victoria
Australia	St. Vincent's Hospital	Melbourne	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Epworth Hospital	Richmond	Victoria
United States	Northwest Texas Healthcare System	Amarillo	Texas
United States	AnMed Health	Anderson	South Carolina
United States	Heart Hospital of Austin	Austin	Texas
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Bay Regional Medical Center	Bay City	Michigan
United States	Overlake Hospital Medical Center	Bellevue	Washington
United States	St. Joseph Hospital	Bellingham	Washington
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Cooper Health System	Camden	New Jersey
United States	Presbyterian Hospital - Charlotte	Charlotte	North Carolina
United States	The Christ Hospital	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	EMH Regional Medical Center	Elyria	Ohio
United States	Thomas Hospital	Fairhope	Alabama
United States	Pinnacle Health @ Harrisburg Hospital	Harrisburg	Pennsylvania
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	St. Vincents Medical Center	Jacksonville	Florida
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	St. Luke's Hospital	Kansas City	Missouri
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	St. Patrick Hospital	Missoula	Montana
United States	Gotham Cardiology	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Mount Sinai Medical Center	NY	New York
United States	Orlando Regional Medical Center	Orlando	Florida
United States	The Methodist Hospital	Pearland	Texas
United States	Sacred Heart Hospital of Pensicola	Pensacola	Florida
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Beaumont Hospital	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Willis Knighton Health System, Pierremont	Shreveport	Louisiana
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Heart Clinics Northwest/ Sacred Heart Medical Center	Spokane	Washington
United States	St. John's Hospital	Springfield	Illinois
United States	Barnes Jewish Hospital	St. Louis	Missouri
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Hillcrest Medical Center	Tulsa	Oklahoma
United States	Washington Hospital Center	Washington	District of Columbia
United States	Iowa Heart Center P.C.	West Des Moines	Iowa
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure (TLF)	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.	1 year	Yes
Primary	Target Lesion Failure (TLF)	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.	2 years	Yes
Primary	Target Lesion Failure (TLF)	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.	3 years	Yes
Secondary	Procedure Time	Procedure time is defined as time between insertion and withdrawal of guide catheter.	From insertion to withdrawal of guide catheter	Yes
Secondary	Device Success (Lesion Basis)	Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).	From the start of index procedure to end of index procedure	Yes
Secondary	Procedural Success (Subject Basis)	Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.	From the start of index procedure to end of index procedure	Yes
Secondary	All Death (Cardiac, Vascular, Non-cardiovascular)		In-hospital is less than or equal to 7 days post index procedure	Yes
Secondary	All Death (Cardiac, Vascular, Non-cardiovascular)		30 days	Yes
Secondary	All Death (Cardiac, Vascular, Non-cardiovascular)		180 days	Yes
Secondary	All Death (Cardiac, Vascular, Non-cardiovascular)		1 year	Yes
Secondary	All Death (Cardiac, Vascular, Non-cardiovascular)		2 years	Yes
Secondary	All Death (Cardiac, Vascular, Non-cardiovascular)		3 years	Yes
Secondary	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.	Yes
Secondary	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	30 days	Yes
Secondary	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	180 days	Yes
Secondary	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	1 year	Yes
Secondary	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	2 years	Yes
Secondary	Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	3 years	Yes
Secondary	Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure	Yes
Secondary	Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	30 days	Yes
Secondary	Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	180 days	Yes
Secondary	Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	1 year	Yes
Secondary	Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	2 years	Yes
Secondary	Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	3 years	Yes
Secondary	Clinically Indicated-Target Lesion Revascularization		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure	No
Secondary	Clinically Indicated-Target Lesion Revascularization		30 days	No
Secondary	Clinically Indicated-Target Lesion Revascularization		180 days	No
Secondary	Clinically Indicated-Target Lesion Revascularization		1 year	No
Secondary	Clinically Indicated-Target Lesion Revascularization		2 years	No
Secondary	Clinically Indicated-Target Lesion Revascularization		3 years	No
Secondary	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure	No
Secondary	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		30 days	No
Secondary	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		180 days	No
Secondary	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		1 year	No
Secondary	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		2 years	No
Secondary	Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		3 years	No
Secondary	All TLR (CI and Non-CI)		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure	No
Secondary	All TLR (CI and Non-CI)		30 days	No
Secondary	All TLR (CI and Non-CI)		180 days	No
Secondary	All TLR (CI and Non-CI)		1 year	No
Secondary	All TLR (CI and Non-CI)		2 years	No
Secondary	All TLR (CI and Non-CI)		3 years	No
Secondary	All TVR (CI and Non-CI)		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure	No
Secondary	All TVR (CI and Non-CI)		30 days	No
Secondary	All TVR (CI and Non-CI)		180 days	No
Secondary	All TVR (CI and Non-CI)		1 year	No
Secondary	All TVR (CI and Non-CI)		2 years	No
Secondary	All TVR (CI and Non-CI)		3 years	No
Secondary	All Coronary Revascularization (TVR and Non-TVR)		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure	No
Secondary	All Coronary Revascularization (TVR and Non-TVR)		30 days	No
Secondary	All Coronary Revascularization (TVR and Non-TVR)		180 days	No
Secondary	All Coronary Revascularization (TVR and Non-TVR)		1 year	No
Secondary	All Coronary Revascularization (TVR and Non-TVR)		2 years	No
Secondary	All Coronary Revascularization (TVR and Non-TVR)		3 years	No
Secondary	Cardiac Death/All MI		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure	Yes
Secondary	Cardiac Death/ All MI	Per Protocol	30 days	Yes
Secondary	Cardiac Death/All MI	Per Protocol	180 days	Yes
Secondary	Cardiac Death/All MI	Per Protocol	1 year	Yes
Secondary	Cardiac Death/All MI	Per Protocol	2 years	Yes
Secondary	Cardiac Death/All MI	Per Protocol	3 years	Yes
Secondary	Cardiac Death/ All MI/CI-TLR		in-hospital	Yes
Secondary	Cardiac Death/ All MI/CI-TLR	Per Protocol	30 days	Yes
Secondary	Cardiac Death/ All MI/CI-TLR	Per Protocol	180 days	Yes
Secondary	Cardiac Death/ All MI/CI-TLR	Per Protocol	1 year	Yes
Secondary	Cardiac Death/ All MI/CI-TLR	Per Protocol	2 years	Yes
Secondary	Cardiac Death/ All MI/CI-TLR	Per Protocol	3 years	Yes
Secondary	All Death/All MI/All Coronary Revascularization	Per Protocol	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure	Yes
Secondary	All Death/All MI/All Coronary Revascularization	Per Protocol	30 days	Yes
Secondary	All Death/All MI/All Coronary Revascularization	Per Protocol	180 days	Yes
Secondary	All Death/All MI/All Coronary Revascularization	Per Protocol	1 year	Yes
Secondary	All Death/All MI/All Coronary Revascularization	Per Protocol	2 years	Yes
Secondary	All Death/All MI/All Coronary Revascularization	Per Protocol	3 years	Yes
Secondary	Stent Thrombosis	Per protocol and per Academic Research Consortium (ARC, definite/probable)	Acute (=1 day)	Yes
Secondary	Stent Thrombosis	Per protocol and per ARC	Subacute (>1 - 30 days)	Yes
Secondary	Stent Thrombosis	Per protocol and per ARC	Acute/Subacute (0 - 30 days)	Yes
Secondary	Stent Thrombosis	Per protocol and per ARC	Late (31 - 393 days)	Yes
Secondary	Stent Thrombosis	Per protocol	Late (31 - 758 days)	Yes
Secondary	Stent Thrombosis	Per ARC, definite and probable	Very Late (394 - 758 days)	Yes
Secondary	Stent Thrombosis	Per protocol	Late (31 - 1123 days)	Yes
Secondary	Stent Thrombosis	Per ARC, definite and probable	Very Late (394 - 1123 days)	Yes
Secondary	Stent Thrombosis	Per protocol and per ARC	Overall (0-393 days)	Yes
Secondary	Stent Thrombosis	Per protocol	Overall (0-758 days)	Yes
Secondary	Stent Thrombosis	Per ARC, definite and probable	Overall (0-758 days)	Yes
Secondary	Stent Thrombosis	Per protocol	Overall (0 - 1123 days)	Yes
Secondary	Stent Thrombosis	Per ARC, definite and probable	Overall (0 - 1123 days)	Yes