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Sponsors and Collaborators: |
Cardiovascular Research Foundation, New York R. Stuart Dickson Institute for Health Studies |
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Information provided by: | Cardiovascular Research Foundation, New York |
ClinicalTrials.gov Identifier: | NCT00638794 |
Prospective, multicenter, registry of at least 11,000 (and up to 15,000) consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.
Condition | Intervention |
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Coronary Artery Disease |
Device: Drug -Eluting Stent (Taxus™, Cypher®, Endeaver™) |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents |
Estimated Enrollment: | 11000 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Surgical
Patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.
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Observational
Consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications
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Device: Drug -Eluting Stent (Taxus™, Cypher®, Endeaver™)
PCI using any FDA approved drug-eluting stent; Taxus Express2 - Paclitaxel-Eluting Coronary Stent System Cypher Sirolimus-eluting coronary stent Endeavor ABT-578 Eluting Coronary Stent System
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To determine:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patient undergoing PCI in whom at least one DES is implanted and in whom PCI of all treated lesions is successful (diameter stenosis <30% with TIMI 3 flow in all treated lesions) without major complications (defined as freedom from procedural death, intraprocedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery).
Inclusion Criteria:
Exclusion Criteria:
Patients in whom blood for Accumetrics VerifyNow platelet function testing cannot be drawn after the minimum clopidogrel loading duration and Glycoprotein (GP) IIb/IIIa inhibitor washout duration as follows:
Contact: Gregg W Stone, MD | (212) 851-9302 | gstone@crf.org |
Contact: Rosemary DeMarco, BSN | (212) 851-9107 | rdemarco@crf.org |
United States, North Carolina | |
Carolinas Medical Center | Recruiting |
Charlotte, North Carolina, United States, 28202 | |
Contact: Michael Rinaldi, MD 704-355-3188 mrinaldi@carolinashealthcare.org | |
Contact: Craig McGregor Craig.McGregor@carolinashealthcare.org | |
Principal Investigator: Michael Rinaldi, MD | |
LeBauer Cardiovascular Research | Recruiting |
Greensboro, North Carolina, United States, 27401 | |
Contact: Bruce Brodie, MD 336-832-2546 | |
Contact: Barbara Bradshaw barbara.bradshaw@mosescone.com | |
Principal Investigator: Bruce Brodie, MD | |
Sub-Investigator: Thomas Stuckey, MD |
Principal Investigator: | Gregg W. Stone, MD | CardioVascular Research Foundation, Korea |
Responsible Party: | Cardiovascular Research Foundation ( Gregg W. Stone, MD, Chairman, Cardiovascular Research Foundation ) |
Study ID Numbers: | ADAPT-DES |
Study First Received: | February 28, 2008 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00638794 |
Health Authority: | United States: Food and Drug Administration |
Myocardial Infarction Myocardial Ischemia |
Sirolimus Arterial Occlusive Diseases Coronary Disease Heart Diseases Paclitaxel Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Infarction Myocardial Infarction Coronary Artery Disease |
Cardiovascular Diseases |