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| Sponsor: | University of Leipzig |
|---|---|
| Collaborator: |
Cordis Medizinische Apparate GmbH |
| Information provided by: | University of Leipzig |
| ClinicalTrials.gov Identifier: | NCT00299429 |
Purpose
Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally invasive bypass surgery in patients with isolated proximal left anterior descending coronary arteries in terms of non-inferiority of an end point combining mortality, acute myocardial infarction and rate of reintervention of the target vessel within one year.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Procedure: Stenting and minimally invasive bypass surgery |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomised Comparison of Minimally Invasive Direct Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention With Drug-Eluting Stents in Patients With Proximal Stenosis of the Left Anterior Descending Coronary Artery |
| Enrollment: | 130 |
| Study Start Date: | January 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Angiographical exclusion criteria:
Contacts and Locations| Germany | |
| University of Leipzig - Heart Center | |
| Leipzig, Germany, 04289 | |
| Principal Investigator: | Holger Thiele, MD | University of Leipzig |
More Information
| Responsible Party: | University of Leipzig - Heart Center ( Dr. Holger Thiele ) |
| Study ID Numbers: | 2-Thiele |
| Study First Received: | September 9, 2005 |
| Last Updated: | July 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00299429 History of Changes |
| Health Authority: | Germany: Ethics Commission |
|
Stent drug-eluting stent Minimally invasive bypass surgery left anterior descending |
|
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |