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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-TAXUS Registry


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General
Application Number P060008 / PAS002
Current Plan Approved 09/29/2014
Study Name OSB Lead-TAXUS Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center study designed to observe clinical outcomes in patients receiving the TAXUS Liberte-Paclitaxel-Eluting Coronary Stent and prasugrel as part of a dual antiplatelet therapy drug regimen. This is a consecutively-enrolled study with follow-up through 5 years. This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy study.
Study Population Description Patients with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention (PCI) with TAXUS Liberté stent placement and no contraindications to prolonged DAPT.
Sample Size Approximately 4,200 consecutive, eligible patients will be enrolled at up to 100 U.S. sites.

Primary Endpoint

Given the non-inferiority margin of 1.6% and a one-sided 5% significance level, 2,363 on-label TAXUS Liberté patients would be required to provide 80% power to test the hypothesis for the primary endpoint.

Secondary Endpoints

A total of 2,100 on-label patients treated with the TAXUS Liberté stent and followed through 3 years post stent index procedure is required. To allow for approximately 3.5% attrition per year, 2,546 on-label patients will be required to provide at least 2,100 on-label patients through 3-year follow-up. This will include 871 patients enrolled in the TAXUS ATLAS Workhorse protocol and 1,675 on-label patients enrolled into the TAXUS Liberté Post Approval Study.
Data Collection The rate of Cardiac Death or Myocardial Infarction (MI) among all on-label patients through 12 months or survive free of Cardiac Death or MI for at least 335 days (Day 365 minus 30 days).

Secondary Endpoints

1. Stent thrombosis (ST) rate, using the historical TAXUS definition in the following populations: overall patient population, TAXUS Liberté on-label population, TAXUS Liberté off-label population.

2. ST rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Revascularization) in the following populations; overall patientpopulation, TAXUS Liberté on-label patient population and off-label patient population.

3. Overall and TAXUS-related MACCE rates (cardiac death, myocardial infarction, target vessel revascularization, stroke).

4. Overall and TAXUS-related cardiac death, MI or stroke rates.

5. Overall and TAXUS-related MACE rates (cardiac death, myocardial infarction, target vessel revascularization).

6. Overall and TAXUS-related cardiac death or MI rates.

7. Overall and TAXUS-related target vessel failure (TVF) rates.

8. Overall and TAXUS-related target vessel revascularization (TVR) rates.

9. Overall and TAXUS-related MI rates.

10. Overall and TAXUS-related cardiac death rates.

11. All cause death rate.

12. Non-cardiac death rate.

13. All death or MI rate.

14. All stroke rate.

15. Rate of bleeding complication will be studied separately for GUSTO classifications severe and moderate as well as for major bleeding (the composite of GUSTO severe + moderate bleeding).
Follow-up Visits and Length of Follow-up Patients will be consecutively-enrolled and followed up through a minimum of three years.

Length of Follow-up

All patients will be followed for a minimum of three years. For patients who are unblinded at 30 months, determined to have been randomized to prasugrel (blinded), and subsequently provided with additional prasugrel: the 36-month follow-up visit should be conducted as an office visit. In addition, a 42-month follow-up visit is required for this subset of patients by telephone or office visit.
Final Study Results
Interim Safety Information Study has just begun, no results available.


OSB Lead-TAXUS Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Summary Report 01/26/2009 01/26/2009 On Time
February Summary Report 03/30/2009 03/30/2009 On Time
April Summary Report 05/01/2009 05/01/2009 On Time
May 2009 Summary Report 05/29/2009 05/28/2009 On Time
June Summary Report 07/02/2009 07/02/2009 On Time
July Summary Report 08/04/2009 08/04/2009 On Time
August Summary Report 09/01/2009 09/01/2009 On Time
Sept Safety Report 10/07/2009 10/07/2009 On Time
Safety Report 11/03/2009 11/03/2009 On Time
Dec Safety Report 12/09/2009 12/04/2009 On Time
Jan Summary Report 01/07/2010 01/07/2010  
6 mth report 06/29/2010 06/29/2010 On Time
1 year report 12/29/2010 12/29/2010 On Time
18 month report 06/29/2011 06/29/2011 On Time
2 year report 12/29/2011 12/27/2011 On Time
3 year report 12/29/2012 12/26/2012 On Time
4 year report 12/29/2013 02/04/2014 Overdue/Received
5 year report 12/29/2014 12/23/2014 On Time
Final Report 10/23/2015 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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