E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent (eFive Registry)
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:
- To document the acute and mid-term safety and overall clinical performance of the stent system in a "real world" patient population requiring stent implantation.
- To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.
|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|
- MACE (Major Adverse Cardiac Events) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery))
|Study Start Date:||September 2005|
|Study Completion Date:||February 2009|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Device: Endeavor Zotarolimus Eluting Coronary Stent
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623441
|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|