Registry Experience at the Washington Hospital Center, Des - Taxus Liberte Versus Xience V (REWARDS TLX)
This study has been completed.
Sponsor:
Medstar Health Research Institute
Collaborator:
Boston Scientific Corporation
Information provided by:
Medstar Health Research Institute
ClinicalTrials.gov Identifier:
NCT01134159
First received: May 27, 2010
Last updated: June 1, 2011
Last verified: June 2011
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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 Health 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 (Adult, Senior) |
| 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
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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
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 Health Research Institute
Boston Scientific Corporation
Investigators
| Principal Investigator: | Ron Waksman, MD | Medstar Health Research Institute |
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 |
| 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 September 29, 2016