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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

Tracking Information
First Submitted Date May 27, 2010
First Posted Date May 31, 2010
Last Update Posted Date June 2, 2011
Study Start Date June 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2010)		 Major adverse cardiac events, [ Time Frame: 1 year ]
A composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 28, 2010)
  • Stent thrombosis [ Time Frame: 1 year ]
  • Target vessel revascularization [ Time Frame: 1 year ]
  • Cardiac death [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry Experience at the Washington Hospital Center, Des - Taxus Liberte Versus Xience V
Official Title Registry Experience at the WAshington Hospital CenteR, DeS - Taxus Liberte vs Xience V
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Coronary Artery Disease
Intervention Not Provided
Study Groups/Cohorts
  • Xience V
    Those who have only received a Xience V stent
  • Taxus Liberte
    Those who have received only a Taxus Liberte stent
Publications * Waksman R, Ghali M, Goodroe R, Ryan T, Turco M, Ring M, McGarry T, Dobies D, Shammas N, Steinberg DH, Swymelar S, Kaneshige K, Torguson R. Percutaneous coronary intervention with second-generation paclitaxel-eluting stents versus everolimus-eluting stents in United States contemporary practice (REWARDS TLX Trial). Am J Cardiol. 2012 Oct 15;110(8):1119-24. doi: 10.1016/j.amjcard.2012.05.050. Epub 2012 Jul 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: May 28, 2010)		 1200
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01134159
Other Study ID Numbers REWARDS TLX
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Ron Waksman, M.D., Cardiovascular Research Institute/ Medstar Health Research Institute
Original Responsible Party Same as current
Current Study Sponsor Medstar Health Research Institute
Original Study Sponsor Same as current
Collaborators Boston Scientific Corporation
Investigators
Principal Investigator: Ron Waksman, MD Medstar Health Research Institute
PRS Account Medstar Health Research Institute
Verification Date June 2011