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Sponsored by: |
Medtronic Vascular |
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Information provided by: | Medtronic Vascular |
ClinicalTrials.gov Identifier: | NCT00614848 |
To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in diameter.
Condition | Intervention |
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Coronary Artery Disease Arterial Occlusive Diseases Coronary Disease Coronary Arteriosclerosis Heart Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis |
Device: Endeavor drug eluting coronary stent |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions |
Enrollment: | 1200 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | May 2009 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Endeavor Drug Eluting Coronary Stent
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Device: Endeavor drug eluting coronary stent
Zotarolimus coated coronary stent (10ug/mm)
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2: Active Comparator
Driver bare-metal coronary stent
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Device: Endeavor drug eluting coronary stent
Zotarolimus coated coronary stent (10ug/mm)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Target lesion / vessel must meet the following criteria:
Exclusion Criteria:
Target lesion has any of the following characteristics:
France | |
Dr. J. Fajedet | |
Clinique Pasteur, France |
Principal Investigator: | J. Fajadet, MD | Clinique Pasteur, France |
Principal Investigator: | Richard E Kuntz, MD, MSc | Harvard Medical School USA |
Principal Investigator: | W. Wijns, MD, PhD | OLV Hospital, Belgium |
Responsible Party: | Medtronic Vascular ( Dr. Kweli Thompson, VP, Clinical Research ) |
Study ID Numbers: | IP034 |
Study First Received: | January 30, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00614848 |
Health Authority: | European Union: European Medicines Agency |
restenosis |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Ischemia Arteriosclerosis Coronary Artery Disease |
Pathologic Processes Cardiovascular Diseases |