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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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5yr Clinical Outcomes


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General
Application Number P060033 / PAS001
Current Plan Approved 02/01/2008
Study Name 5yr Clinical Outcomes
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is design to obtain long term follow-up of the premarket study cohort patients.
Study Population Description 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.
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
Data Collection Endeavor IV: The primary endpoint was target vessel failure at 9 months post-procedure.
Follow-up Visits and Length of Follow-up Annually to five years
Final Study Results
Interim Safety Information 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.
Number of Patients Overall, there are a total of 3,621 patients enrolled for Endeavor trials.
Number of Sites Overall, there are a total of 210 study sites enrolling patients for Endeavor trials (I, II, II-CA, III, IV, and PK).
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.
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.
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.

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.

Label Changes Labeling changes are being requested.


5yr Clinical Outcomes Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 01/31/2009 01/27/2009 On Time
2 year report 01/31/2010 01/29/2010 On Time
3 year report 01/31/2011 01/27/2011 On Time
4 year report-final report 01/31/2012 01/13/2012 On Time
response to R19 RDEF final report 05/12/2012 05/11/2012 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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