E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent (eFive)
|ClinicalTrials.gov Identifier: NCT00623441|
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : December 16, 2011
Last Update Posted : November 23, 2015
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.
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: Endeavor Zotarolimus Eluting Coronary Stent|
|Study Type :||Observational|
|Actual Enrollment :||8314 participants|
|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|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||February 2009|
Device: Endeavor Zotarolimus Eluting Coronary Stent
- MACE (Major Adverse Cardiac Events) [ Time Frame: 12 Months ]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))
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|