Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-01 @ 4:16 PM
Study NCT ID:
NCT01134159
Status:
COMPLETED
Last Update Posted:
2011-06-02
First Post:
2010-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry Experience at the Washington Hospital Center, Des - Taxus Liberte Versus Xience V
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-01', 'studyFirstSubmitDate': '2010-05-27', 'studyFirstSubmitQcDate': '2010-05-28', 'lastUpdatePostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac events,', 'timeFrame': '1 year', 'description': 'A composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization'}], 'secondaryOutcomes': [{'measure': 'Stent thrombosis', 'timeFrame': '1 year'}, {'measure': 'Target vessel revascularization', 'timeFrame': '1 year'}, {'measure': 'Cardiac death', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '22762711', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients male or female, 18 years or older whom have undergone PCI with either Taxus Liberte or Xience V', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older, both genders\n* Underwent PCI with Taxus Liberte (alone) or Xience (alone)\n\nExclusion Criteria:\n\n* Underwent PCI with a non-Taxus Liberte or Xience V DES during the same procedure\n* Received both Taxus-Liberte and Xience-V during the same index procedure\n* Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel or prasugrel).'}, 'identificationModule': {'nctId': 'NCT01134159', 'acronym': 'REWARDS TLX', 'briefTitle': 'Registry Experience at the Washington Hospital Center, Des - Taxus Liberte Versus Xience V', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Registry Experience at the WAshington Hospital CenteR, DeS - Taxus Liberte vs Xience V', 'orgStudyIdInfo': {'id': 'REWARDS TLX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Xience V', 'description': 'Those who have only received a Xience V stent'}, {'label': 'Taxus Liberte', 'description': 'Those who have received only a Taxus Liberte stent'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Midwest Cardiovascular Research Foundation', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '20913', 'city': 'Takoma Park', 'state': 'Maryland', 'country': 'United States', 'facility': 'Washington Adventist Hospital', 'geoPoint': {'lat': 38.97789, 'lon': -77.00748}}, {'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'facility': 'Genesys Regional Medical Center', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Foundation for Cardiovascular Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29575', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Grand Strand Regional Medical Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Heart Clinics Northwest', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Ron Waksman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medstar Health Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Ron Waksman, M.D.', 'oldOrganization': 'Cardiovascular Research Institute/ Medstar Health Research Institute'}}}}