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

Medtronic

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Endeavor Zotarolimus Eluting Coronary Stent

Study type: Observational

Funder types: Industry

Identifiers

NCT00623441

Protocol Final version1.1

Details and patient eligibility

About

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.

Enrollment: 8,314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.