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
The purpose of this study is to evaluate the effectiveness and safety 12 versus 30
months of dual antiplatelet therapy on the composite of all death, myocardial infarction and stroke free survival, as well as definite or probable ST free survival, in patients treated with drug eluting stents. The patients will be randomized to either their dual anti-platelet therapy or placebo and followed from 12 months to 30 months post index procedure.
Study Population Description
The Xience V Everolimus Eluting Coronary Stent System was approved on July 2, 2008. This
device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length < 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm.Study population will consist of event free patients at 12 months
Sample Size
Study Phase I (From index procedure to 1 year post stent implantation):8,000 patients, Study Phase
II (From 1 year up to 5 years) : All patients enrolled and completed Study Phase I will be evaluated at 1-year to determine their eligibility of participating in one of the three different study cohorts in Study Phase II:1) XIENCE V USA LTF Cohort: The first 1,500 on-label patients and the remaining patients from the initial 5,000 patients who do not participate in the HCRI-DAPT cohort will be included in this cohort. 2) HCRI-DAPT Cohort: Patients who are event free in the first year and are compliant with DAPT will be identified for HCRI. 3) AV-DAPT Cohort: Up to 1,524 patients from the additional 3,000 patients who are event free in the first year and are compliant with DAPT will be included in this cohort. The approximately 440 sequentially enrolled patients from 3,841 to 5,060 that are not included in the HCRI-DAPT study will also be followed to five years post index procedure. Therefore, a total of 4,280 patients (3,840 + 440) will be followed to five years post index procedure by Abbott Vascular. The remaining 780 patients will be followed by HCRI for the HCRI-DAPT study, 275 sites
Data Collection
Annual rates of ST cardiac death and myocardial infarction will be determined.
Followup Visits and Length of Followup
Annually to five years. Clinical follow-up will occur at 15, 24, 30 and 33 months.
