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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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TAXUS Long (S011)


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General
Application Number P060008 S011/ PAS001
Current Plan Approved 07/23/2010
Study Name TAXUS Long (S011)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent 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 The TAXUS Liberté Long Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. The stent is mounted over a deflated balloon attached to the end of a long thin flexible tube called a stent delivery catheter. The stent is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >=2.75 mm to <=4. 00 mm in diameter in lesions <=34 mm in length.
Sample Size 84 subjects, 100 sites
Data Collection Data will be collected on the rate of cardiac death or myocardial infarction through 12 months. This will be compared with the cardiac death or myocardial infarction rates observed through 12 months in control arm of the TAXUS ATLAS Workhorse Clinical Trial and the ARRIVE 1 and 2 registries.
Follow-up Visits and Length of Follow-up Patient follow up will occur at months 6, 12, 15, 18, 24, 30, 33, 36, 48 and 60 post index procedure, for all enrolled patients. Follow-up for months 15, 33, 36, 48 and 60 may be conducted via telephone. Follow-up for months 6, 12, 18, 24 and 30 must be conducted during a clinical visit for the purposes of study drug dispensing and accountability. The 18-month office visit is intended to serve the purposes of drug dispensing and accountability only.
Final Study Results
Interim Safety Information The study has recently started, no results available.
Number of Patients 150
Number of Sites 24
Follow-up Rate 90.2%
Safety Findings ¿MACE: out-of-hospital MACE to 5 years was comparable for the groups (32.6% for the TAXUS® ATLAS Group and 27.6% for the Control Group, P=0.3790).

¿Stent Thrombosis: Stent thrombosis rates were not statistically different for the TAXUS® ATLAS Group versus the Control Group (2.5% versus 0.9%, P=0.6220)

¿All Death: Rates through 5 years were comparable between the TAXUS® ATLAS Group and the Control Group (11.1% versus 10.9%, P=0.9465).

¿Non-cardiac Death: Rates through 5 years were not statistically different the TAXUS® ATLAS Group and the Control Group (7.0% versus 2.5%, P=0.1054).



Effect Findings ¿MACE (cardiac death, MI, and TVR): The rate at 5 years was comparable between the TAXUS® ATLAS Group and the Control Group (32.6% versus 30.7%, respectively).

¿Cardiac Death: Rates through 5 years were comparable for the TAXUS® ATLAS Group and the Control Group (4.5% versus 8.7%).

¿MI: Rates through 5 years were comparable for the TAXUS® ATLAS Group and the Control Group (7.6% versus 11.8%).

¿TVR: The rate at 5 years was comparable for the TAXUS® ATLAS Group versus the Control Group (25.8% versus 20.5%).

¿TLR: The rate at 5 years was comparable for the TAXUS® ATLAS Group versus the Control Group (18.9% versus 14.2%).

¿TVF: The rate at 5 years was comparable for the TAXUS® ATLAS Group versus the Control Group (30.5% versus 28%.

*The study was not powered for these endpoints at 5 years

Strengths & Weaknesses Sponsor had a high follow-up rate. The stent thrombosis rate was higher in the treatment group. The study was not adequately powered to detect differences in stent thrombosis rates.
Label Changes Yes, to update with the five year final study results.


TAXUS Long (S011) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/11/2010 02/03/2010 Overdue/Received
18 month report 01/11/2011 11/26/2010 On Time
2 year report 07/13/2011 06/01/2011 On Time
3 year report-FINAL REPORT 07/12/2012 12/16/2011 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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