In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
Endeavor IV: The primary endpoint was target vessel failure at 9 months post-procedure.
Followup Visits and Length of Followup
Annually to five years
Final Study Results
Actual Number of Patients Enrolled
Overall, there are a total of 3,621 patients enrolled for Endeavor trials.
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).
Patient Followup 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.
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.
Final Effectiveness 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.
Study Strengths and 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.
