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

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01134159
First received: May 27, 2010
Last updated: June 1, 2011
Last verified: June 2011
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Registry Experience at the WAshington Hospital CenteR, DeS - Taxus Liberte vs Xience V

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • Major adverse cardiac events, [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization


Secondary Outcome Measures:
  • Stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Target vessel revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cardiac death [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Xience V
Those who have only received a Xience V stent
Taxus Liberte
Those who have received only a Taxus Liberte stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Research Institute
Boston Scientific Corporation
Investigators
Principal Investigator: Ron Waksman, MD Medstar Research Institute
  More Information

No publications provided by Medstar Research Institute

Additional 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
Study First Received: May 27, 2010
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014