f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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TAXUS (IDE)


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General
Study Status Completed
Application Number /
Requirement Number		 P030025 / PAS002
Date Original Protocol Accepted 03/04/2004
Date Current Protocol Accepted  
Study Name TAXUS (IDE)
Device Name TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
General Study Protocol Parameters
Study Design Randomized Clinical Trial
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 Objectives This study is a follow-up of the pre-market cohort.
Study Population This device is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >2. 25 to <4. 0mm in diameter in lesions < 28mm in length. The study population consisted of individuals in the original IDE study population.
Sample Size TAXUS IV 662 patients, TAXUS V 556, 76 sites
Key Study Endpoints No endpoints were specified.
Follow-up Visits and Length of Follow-up Annually to five years
Interim or Final Data Summary
Actual Number of Patients Enrolled 1218 patients
Actual Number of Sites Enrolled 76 sites
Patient Follow-up Rate 95%
Final Safety Findings The major adverse cardiac event rates over time were significantly lower for TAXUS treatment group as compared with the Control arm. Through 5 years, the event rate was 24.0% in the TAXUS group compared with 32.8% for the Control group, for a relative percent change of 26.9%.
Study Strengths & Weaknesses Strengths: The sponsor had excellent patient follow-up at 95%. Weaknesses: There was no postapproval followup protocol.
Recommendations for Labeling Changes There were no recommendations for changes to the labeling based on the results of the post-approval study.


TAXUS (IDE) Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final TAXUS IV Report 03/04/2008 02/28/2008 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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