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.
Prospective, single-arm, open-label, US multi-center registry study to evaluate the safety and effectiveness of the
2.25 mm XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.
150 subjects enrolled at up to 75 sites in the United States
The primary endpoint is the composite rate of cardiac death, target vessel myocardial infarction (MI)
(per protocol definition), and clinically indicated target lesion revascularization (CI-TLR) at 1 year. This endpoint meets a pre-specified performance goal of XXX derived from the 2.25 mm DES data that was obtained in a literature review.
Followup Visits and Length of Followup
Clinical F/U: 30 days (clinic visit), 240 days and 1 year (clinic visit), 2, 3,
4, 5 years (clinic or telephone visit).
Angiographic F/U: 240 days (only subjects in the angiographic cohort who received a 2.25 mm XIENCE V EECS are eligible).
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
The overall (0 - 1123 days) definite/probable stent thrombosis rate per ARC was 1.5% (2/130).
Final Effectiveness Findings
-MACE Rates at 3 years: 12.1% (16/132)
-TVR rates at 3 years: 13.6% (18/132)
-TLF rates at
3 years: 12.1% (16/132)
-Cardiac Death rates at 3 years: 3.8% (5/132)
Study Strengths and Weaknesses
Results provide further evidence of the clinical utility and safety of this device. The study
had an acceptable rate of attrition, thus minimizing selection bias.
Recommendations for Labeling Changes
A labeling change is recommended to add a summary of the post-approval study results including
study strengths and limitations. The updated label will reflect the long-term performance of the device from the pre-market cohort.