The ELUTES Clinical Trial (ELUTES I)

Cook Group

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: coronary stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00225654

505

Details and patient eligibility

About

ELUTES is a European multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Paclitaxel Eluting V-Flex Plus coronary stent to reduce restenosis in the coronary artery.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
Patient must be an acceptable candidate for coronary artery bypass surgery.
Patient or legal guardian must have signed informed consent.
Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.

Exclusion criteria

Patient must be less than 18 years old.
Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
Women of child bearing potential.
Patient has other medical condition that may cause non-compliance with the protocol, confound the results, or is associated with limited life expectancy.
Patient has been diagnosed with a myocardial infarction within 72 hours prior to procedure.