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.
The objective of the Dual Antiplatlet 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 ARC definite or probable ST free survival, in patients treated with drug eluting stents. The patients will be randomized to either their DAPT or placebo and followed from 12 months to 30 months post index procedure.
Study Population Description
This device is indicated for improving luminal diameter for the treatment of de novo lesions
< 28 mm in length in native coronary arteries > 2.5 mm to < 4.0 mm in diameter. Study patients with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention with TAXUS Liberté stent placement and no contraindications to prolonged dual antiplatlet therapy are eligible to be enrolled in this study.
1,524 patients who receive 12 months of dual antiplatelet therapy, 100 sites
The endpoints include annual rates of ST, cardiac death and myocardial infarction.
Followup Visits and Length of Followup
Patients will be followed annually to five years. Clinical follow-up will occur at 15, 24,