Registry Experience at the Washington Hospital Center, Des - Taxus Liberte Versus Xience V (REWARDS TLX)

June 1, 2011 updated by: Medstar Health Research Institute

Registry Experience at the WAshington Hospital CenteR, DeS - Taxus Liberte vs Xience V

Multicenter, retrospective registry to collect 9-12 month follow-up data to evaluate major adverse cardiac events in patients whom have undergone percutaneous coronary intervention and received either Taxus Liberte or Xience V.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Midwest Cardiovascular Research Foundation
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Maryland
      • Takoma Park, Maryland, United States, 20913
        • Washington Adventist Hospital
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Foundation for Cardiovascular Research
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Myrtle Beach, South Carolina, United States, 29575
        • Grand Strand Regional Medical Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Heart Clinics Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients male or female, 18 years or older whom have undergone PCI with either Taxus Liberte or Xience V

Description

Inclusion Criteria:

  • Patients 18 years of age or older, both genders
  • Underwent PCI with Taxus Liberte (alone) or Xience (alone)

Exclusion Criteria:

  • Underwent PCI with a non-Taxus Liberte or Xience V DES during the same procedure
  • Received both Taxus-Liberte and Xience-V during the same index procedure
  • Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel or prasugrel).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Xience V
Those who have only received a Xience V stent
Taxus Liberte
Those who have received only a Taxus Liberte stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events,
Time Frame: 1 year
A composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac death
Time Frame: 1 year
1 year
Target vessel revascularization
Time Frame: 1 year
1 year
Stent thrombosis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Ron Waksman, MD, MedStar Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

May 28, 2010

First Posted (Estimate)

May 31, 2010

Study Record Updates

Last Update Posted (Estimate)

June 2, 2011

Last Update Submitted That Met QC Criteria

June 1, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REWARDS TLX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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