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| Sponsor: | Medtronic Bakken Research Center |
|---|---|
| Information provided by (Responsible Party): | Medtronic Bakken Research Center |
| ClinicalTrials.gov Identifier: | NCT00623441 |
Purpose
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 |
|---|---|
|
Coronary Artery Disease |
Device: Endeavor Zotarolimus Eluting Coronary Stent |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: 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 |
| Enrollment: | 8314 |
| Study Start Date: | September 2005 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | November 2007 (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 |
| Sampling Method: | Non-Probability Sample |
Real-world patients requiring drug eluting stent implantation
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Medtronic Bakken Research Center |
| ClinicalTrials.gov Identifier: | NCT00623441 History of Changes |
| Obsolete Identifiers: | NCT00265668 |
| Other Study ID Numbers: | Protocol Final version1.1 |
| Study First Received: | February 18, 2008 |
| Results First Received: | September 1, 2009 |
| Last Updated: | January 27, 2012 |
| Health Authority: | Not required: N/A |
|
Coronary Artery Disease Drug-eluting stent |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |