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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Dual Antiplatelet Study


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General
Application Number P060008 / PAS003
Current Plan Approved 01/21/2014
Study Name OSB Lead-Dual Antiplatelet Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of the Dual Antiplatlet Study is to evaluate

multiple durations of DAPT following DES implantation to determine the optimal duration. 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. Patients randomized to the control group will receive placebo.

Sample Size Up to 4200 patients will be randomized for participation in

DAPT. The sample size is estimated based on the expected follow-up rate.

Data Collection No endpoints are specified for the descriptive analyses of

the DAPT study.

Secondary Endpoints: Stent thrombosis, cardiac death, myocardial infarction, target vessel revascularization, stroke, target vessel failure, and bleeding complication.

Follow-up Visits and Length of Follow-up 60 months post index procedure
Final Study Results
Interim Safety Information No results can be shared since this study is being conducted under an IDE.
Number of Patients Overall: 4, 199 subjects

On-label: 1,592 subjects

Number of Sites 82 sites
Follow-up Rate Overall: At three years: 85.8% (3579/4173) On-label: At three years: 86.3% (1370/1588)
Safety Findings The primary endpoint (12-month Cardiac Death or myocardial infarction) was met as the difference of -0.9%, with a 1-sided 95% upper confidence limit of -0.2%, was less (P<0.001) than the pre-specified non-inferiority margin of 1.6%.



The annualized stent thrombosis rate on on-label subjects met the pre-specified performance goal. It was 0.56% between 1 and 2 years (upper 1-sided 95% confidence limit (95% UCL):

0.82%) which was below the 1.0% performance goal (P=0.0025). Between 2 and 3 years, it was

0.51% (1-sided 95% UCL: 0.76%, p<0.001).



The secondary endpoint related to on-label subjects with diabetes also met its performance goal. The 12-month target vessel failure rate of 5.1% (1-sided 95% UCL 6.8%) was less (P<0.001) than the pre-specified non-inferiority performance goal of 12.6%.

Strengths & Weaknesses This study provides longer term (3 years) safety and effectiveness results of the TAXUS Liberté paclitaxel-eluting coronary stent system. This post-approval study contributed subjects to the Dual Antiplatelet Therapy (DAPT) trial, an industry/academic research organization/FDA collaboration with the Harvard Clinical Research Institute. This study supports the safety and effectiveness results of the premarket data on the TAXUS Liberté paclitaxel-eluting coronary stent system.
Label Changes Labeling changes are not recommended since this device is no longer on the market.


OSB Lead-Dual Antiplatelet Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's 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 12/20/2013 On Time
5 year report 12/26/2014 12/23/2014 On Time
Final Report 10/02/2015 10/02/2015 On Time


Contact Us

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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