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Sponsored by: |
Medtronic Bakken Research Center |
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Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00623441 |
The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been assessed in a series of studies. The stent is coated with a proprietary drug compound that is designed to reduce restenosis.
This prospective multi-center study has been initiated:
Condition | Intervention |
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Coronary Artery Disease |
Device: Endeavor Zotarolimus Eluting Coronary Stent |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | E-Five Registry: To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor ABT-578 Eluting Coronary Stent System; A Prospective, Multicenter Registry |
Estimated Enrollment: | 8000 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Real-world patients requiring drug eluting stent implantation
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Ian T Meredith, MD | Monash Medical Centre, Melbourne, Australia |
Principal Investigator: | Chaim Lotan, MD | Hadassah University Hospital, Jerusalem, Israel |
Principal Investigator: | Martin T Rothman, MD | London Chest Hospital, London, United Kingdom |
Responsible Party: | Medtronic Bakken Research Center ( Sofia Pateraki/Clinical Research Specialist Vascular ) |
Study ID Numbers: | Protocol version1.1_19-07-2005 |
Study First Received: | February 18, 2008 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00623441 |
Health Authority: | Not required: N/A |
Coronary Artery Disease Drug-eluting stent |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |