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NCT01134159 Clinical Trial

Registry Experience at the Washington Hospital Center, Des - Taxus Liberte Versus Xience V

Coronary Artery Disease Clinical Trial

— REWARDS TLX  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01134159
Other study ID # REWARDS TLX
Secondary ID
Status Completed
Phase N/A
First received May 27, 2010
Last updated June 1, 2011
Start date June 2010
Est. completion date September 2010

Study information
Verified date June 2011
Source Medstar Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1200
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States Midwest Cardiovascular Research Foundation Davenport Iowa
United States Genesys Regional Medical Center Grand Blanc Michigan
United States Grand Strand Regional Medical Center Myrtle Beach South Carolina
United States Oklahoma Foundation for Cardiovascular Research Oklahoma City Oklahoma
United States Maine Medical Center Portland Maine
United States Heart Clinics Northwest Spokane Washington
United States Washington Adventist Hospital Takoma Park Maryland
United States Washington Hospital Center Washington District of Columbia
United States Iowa Heart Center West Des Moines Iowa

Sponsors (2)
Lead Sponsor Collaborator
Medstar Research Institute Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major adverse cardiac events, A composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization 1 year No
Secondary Stent thrombosis 1 year No
Secondary Target vessel revascularization 1 year No
Secondary Cardiac death 1 year No
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