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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 ATLAS Small Vessel


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General
Application Number P060008 S008/ PAS001
Current Plan Approved 07/23/2009
Study Name TAXUS ATLAS Small Vessel
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 Population Description The TAXUS Liberté Atom (2.25 mm) 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 > 2.25 mm to < 4.00 mm in diameter in lesions < 28 mm in length.
Sample Size 168 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 261 TAXUS ATLAS patients, 75 DES control, 155 BMS control
Number of Sites 23
Follow-up Rate 91.3% TAXUS ATLAS, 90.4% DES Control, 85.5% BMS Control. These percentages include patients who died in both the numerator and denominator.
Safety Findings MACE (cardiac death, MI, and TVR): The rate at 5 years was 26.3 in the TAXUS ATLAS Group and 36.9% in the DES Control group and 44.4% in the BMS Control group.
Effect Findings TVR, TLR and TVF rates at 5 years were 20.1%, 13.4% and 25.6%, respectively, for the TAXUS ATLAS Group. The rates for the DES Control Group were 30.8% (TVR), 23.1% (TLR) and 35.4% (TVF). The rates for the BMS Control Group were: 38.3% (TVR), 32.3% (TLR), and 42.9% (TVF).
Strengths & Weaknesses The sponsor present a well designed study with a control group with good follow-up at 5 years.
Label Changes Updated to include the long-term post-approval study data and findings.


TAXUS ATLAS Small Vessel Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Clinical Outcomes Report 09/21/2009 09/18/2009 On Time
2 year report 05/21/2011 11/24/2010 On Time
3 year report 05/20/2012 05/18/2011 On Time
4 year report-FINAL REPORT 05/20/2013 12/09/2011 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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