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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®, Endeavor™, Xience V™) |
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®, Endeavor™, Xience V™)
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 Xience V Everolimus 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:
Patients 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, intra-procedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery). One or more bare metal stents (BMS) may be implanted, and other lesions may be treated without stenting as long as at least one DES is implanted.
However, the procedure must be successful and uncomplicated (as defined above) for all lesions (DES + BMS + non-stent).
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: Louise Gambone | (212) 851-9390 | lgambone@crf.org |
United States, Indiana | |
Indiana Heart Institute | Withdrawn |
Indianapolis, Indiana, United States, 46260 | |
United States, Minnesota | |
Minneapolis Heart Institute | Recruiting |
Minneapolis, Minnesota, United States, 55407 | |
Contact: Tim Henry, MD 612-863-3834 henry003@umn.edu | |
Contact: Dave Chose 612-863-3834 david.chose@allina.com | |
Principal Investigator: Tim Henry, MD | |
Sub-Investigator: Ivan Chavez, MD | |
United States, New York | |
Columbia University Medical Center & New York Presbyterian | Recruiting |
New York, New York, United States, 10027 | |
Contact: Giora Weisz, MD 212-305-2500 | |
Contact: Andy Morales 212-342-1820 am2513@columbia.edu | |
Principal Investigator: Giora Weisz, MD | |
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 704-355-1359 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 | |
FirstHealth Moore Regional Hospital | Recruiting |
Pinehurst, North Carolina, United States, 28374 | |
Contact: Peter Duffy, MD 910-715-1591 pld@nc.rr.com | |
Contact: Karen Borak 910-715-1591 kborak@firsthealth.org | |
Principal Investigator: Peter Duffy, MD | |
United States, Ohio | |
Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Sean Miller 614-247-2127 sean.miller2@osumc.edu | |
Principal Investigator: Ernest Mazzaferri, MD | |
United States, Pennsylvania | |
Lehigh Valley Hospital and Health Network | Recruiting |
Allentown, Pennsylvania, United States, 18105 | |
Contact: David Cox, MD 610-402-2273 dcox@ptd.net | |
Contact: Curt Trapp 610-402-8249 curtis.trapp@lvh.com | |
Principal Investigator: David Cox, MD | |
United States, Tennessee | |
Wellmont Holston Valley Medical Center | Recruiting |
Kingsport, Tennessee, United States, 37660 | |
Contact: Christopher Metzger, MD 423-230-5000 cmetzger@theheartcenter.net | |
Contact: Sarah Wilson 423-502-3273 swilson@theheartcenter.net | |
Principal Investigator: Christopher Metzger, 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, 2009 |
ClinicalTrials.gov Identifier: | NCT00638794 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Myocardial Infarction Myocardial Ischemia |
Arterial Occlusive Diseases Sirolimus Everolimus Heart Diseases Myocardial Ischemia Vascular Diseases Ischemia |
Arteriosclerosis Coronary Disease Paclitaxel Infarction Myocardial Infarction Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |