E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00623441
• Lead Sponsor: Medtronic Bakken Research Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2007-11
• Study First Submitted: 2008-02-18
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-02-26
• Study Completion: 2009-02
• Results First Submitted: 2009-09-01
• Results First Submitted QC: 2011-11-14
• Results First Posted: 2011-12-16
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8314

Inclusion Criteria

• Patient is >18 years of age (or minimum age as required by local regulation)
• The patient has consented to participate by signing the "Patient Informed Consent Form" and/or has authorized the collection and release of his medical information by signing the "Patient Data Release Consent Form".
• The patient is suitable for implantation of one or more Endeavor(TM) ABT-578 Eluting Coronary Stent System in one or more native artery target lesions.
• Lesion length and vessel diameter of the target lesion(s) are according to the "Indications for Use" as mentioned in the "Instructions for Use" that comes with every Endeavor(TM) ABT-578 Eluting Coronary Stent System.
• The patient is willing and able to cooperate with registry procedures and required follow up visits.

Exclusion Criteria

• Women with known pregnancy or who are lactating.
• Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
• Patients in whom anti-platelet and/pr anticoagulation therapy is contraindicated.
• Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
• Current medical condition with a life expectancy of less than 12 months.
• The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this E-five registry once.
• Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE (Major Adverse Cardiac Events)	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))