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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060033 / PAS001 |
| Date Original Protocol Accepted |
02/01/2008
|
| Date Current Protocol Accepted |
02/01/2008
|
| Study Name |
5yr Clinical Outcomes
|
| Device Name |
ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
Sponsor Registry
|
| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is design to obtain long term follow-up of the premarket study cohort patients.
|
| Study Population |
This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length < 27mm in native coronary arteries with reference vessel diameters of > 2.5mm to < 3.5 mm.
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| Sample Size |
Endeavor I: 100 patients, 8 sites; Endeavor II: 1197 patients, 72 sites; Endeavor II CA: 296 patients, 15 sites; Endeavor III: 436 patients, 29 sites; Endeavor IV: 1548 patients, 80 sites; Endeavor PK: 43 patients, 6 sites
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| Key Study Endpoints |
Endeavor IV: The primary endpoint was target vessel failure at 9 months post-procedure.
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| Follow-up Visits and Length of Follow-up |
Annually to five years
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| Interim or Final Data Summary |
| Interim Results |
Endeavor IV: The overall rate of 36-month major adverse cardiac events was 11.4% (84/734) for the Endeavor subjects vs. 13.8% (101/724) for the Taxus subjects. Between 720 and 1080 days postprocedure in the Endeavor arm, 11 subjects experienced the following new major adverse cardiac events: 1 cardiac death, 5 non-cardiac deaths, 1 NQWMI, and 4 TLRs. For Taxus, 25 subjects experienced new major adverse cardiac events consisting of 7 cardiac deaths, 6 non-cardiac deaths, 1 QWMI, 5 NQWMI, and 10 target lesion revascularization. In the Endeavor arm the target vessel failure rate at 1080 days was 12.4% (91/734) compared with 16.1% (118/734) in the Taxus arm (p=0.052). The target lesion revascularization rate at 1080 days in the Endeavor arm was 6.5% (48/734) compared with 6.0% (44/734) in the Taxus arm (p=0.747). The target lesion revascularization rate at 1080 days in the Endeavor arm was 9.9% (73/734) compared with 10.9% (80/734) in the Taxus arm.
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| Actual Number of Patients Enrolled |
Overall, there are a total of 3,621 patients enrolled for Endeavor trials.
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| Actual Number of Sites Enrolled |
Overall, there are a total of 210 study sites enrolling patients for Endeavor trials (I, II, II-CA, III, IV, and PK).
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| Patient Follow-up Rate |
60-month follow-up is complete on 97%, 96.8%, 96.9%, 88%, 93%, and 100% of patients enrolled in Endeavor I, II, II-CA, III, IV, and PK, respectively.
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| Final Safety Findings |
The cumulative 5-year MACE rates were 7.2% (7/97), 15.4% (89/577), 17.8% (51/287), 14.0% (43/307), 17.9% (129/722) and 20.9% (9/43) in Endeavor I, II, II-CA, III, IV, and PK, respectively.
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| Final Effect Findings |
The cumulative 5-year TVF rates were 5.2% (5/97), 15.4% (89/577), 21.6% (62/287), 17.9% (55/307), 17.3% (125/722), and 27.9% (12/43) in Endeavor I, II, II-CA, III, IV, and PK, respectively.
The cumulative 5-year TLR rates were 3.1% (3/97), 7.5% (43/577), 7.3% (21/287), 8.1% (25/307), 7.8% (56/722), and 7.0% (3/43) in Endeavor I, II, II-CA, III, IV, and PK, respectively.
The cumulative 5-year TVR rates were 5.2% (5/97), 10.7% (62/577), 16.4% (47/287), 16.9% (52/307), 12.7% (92/722), and 18.6% (8/43) in Endeavor I, II, II-CA, III, IV, and PK, respectively.
The cumulative 5-year ARC definite+probable ST rates were 1% (1/97), 0.9% (5/577), 0% (0/287), 0.7% (2/307), 1.4% (10/722), and 2.3% (1/43) in Endeavor I, II, II-CA, III, IV, and PK, respectively.
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| Study Strengths & Weaknesses |
Strength:
The follow-up rates for all Endeavor trials meet the requirement of 80% specified in the condition of approval #1.
Weakness:
The sample size for the Endeavor PK is too small to make any definitive conclusions of safety and effectiveness.
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| Recommendations for Labeling Changes |
Labeling changes are being requested.
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