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

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ClinicalTrials.gov Identifier: NCT01134159
Recruitment Status : Completed
First Posted : May 31, 2010
Last Update Posted : June 2, 2011
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Medstar Health Research Institute

Study Description
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Brief 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.

Condition or disease
Coronary Artery Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Registry Experience at the WAshington Hospital CenteR, DeS - Taxus Liberte vs Xience V
Study Start Date : June 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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


Outcome Measures
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Primary Outcome Measures :
  1. Major adverse cardiac events, [ Time Frame: 1 year ]
    A composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization


Secondary Outcome Measures :
  1. Stent thrombosis [ Time Frame: 1 year ]
  2. Target vessel revascularization [ Time Frame: 1 year ]
  3. Cardiac death [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134159


Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Iowa
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52803
Iowa Heart Center
West Des Moines, Iowa, United States, 50266
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20913
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
United States, Oklahoma
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States, 73120
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, United States, 29575
United States, Washington
Heart Clinics Northwest
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Medstar Health Research Institute
Boston Scientific Corporation
Investigators
Principal Investigator: Ron Waksman, MD Medstar Health Research Institute
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ron Waksman, M.D., Cardiovascular Research Institute/ Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT01134159     History of Changes
Other Study ID Numbers: REWARDS TLX
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases