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TAXUS Libertē Post Approval Study

NCT00997503 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4199

Last updated 2015-08-07

Study results available
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Summary

The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen.

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 (DAPT Study).

Conditions

Interventions

DEVICE

TAXUS Liberté Paclitaxel-Eluting Coronary Stent

The TAXUS Liberté Paclitaxel-Eluting Coronary Stent System is a device/drug combination product comprised of two regulated components: a device (Liberté Coronary Stent System) and a drug product (a formulation of paclitaxel contained in a polymer coating).The polymer coating serves as a carrier system to provide uniform and controlled biphasic release of the drug into the vessel wall once the stent is deployed.

DRUG

prasugrel

10mg or 5mg, oral, once daily as maintenance dose through 30-months following index procedure

DRUG

placebo

Oral placebo to match both 10mg and 5mg prasugrel tablets.

DRUG

aspirin

Oral, as prescribed by physician through end of study. .

Sponsors & Collaborators

Principal Investigators

  • David P Lee, MD · Stanford University

  • Kirk N Garratt, MD · Lenox Hill Hospital

  • Peter M Maurer, MPH · Boston Scientific Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-03-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00997503 on ClinicalTrials.gov