Post-Approval Studies

Post-Approval Studies

• 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.

Links

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Webpage FAQs
• Tools for Conducting PAS
• Letter to IRB Chairs (formerly referred to as "IRB Letter from Dr. Schultz (dated 2/9/09)"
• Letter to PAS Participants
• Letter to PAS Investigators
• Post-Approval Studies Workshops
• Report on Implementation of Post-Approval Studies for Medical Devices Workshop (June 2009)

Contact Information

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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General

Application Number

P060008

Protocol Approved

08/28/2010

Study Name

Dual Antiplatelet Study

Study Status

Progress Adequate

General Study Protocol Parameters

Study Design

Randomized Clinical Trial

Study involve follow-up of premarket cohort (Y/N)

No

Data Source

New Data Collection

Comparison Group

Concurrent Control

Analysis Type

Analytical

Study Population

Transitional Adolescent B: 18-21 yrs, Adult: >21

Detailed Study Protocol Parameters

Study Design Description

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.

 

Sample Size

1,524 patients who receive 12 months of dual antiplatelet therapy, 100 sites

Data Collection

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,

30 and 33 months.

 

Dual Antiplatelet Study Schedule

Report Schedule	Report Date Due	FDA Receipt Date	Reporting Status
18 month report	06/29/2011	06/29/2011	On Time
24 month report	12/27/2011	12/27/2011	On Time
36 month report-3 year report	12/27/2012	12/26/2012	On Time
4 year report	12/26/2013
5 year report	12/26/2014

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