V-Flex Plus PTX Drug Eluting Coronary Stent (ELUTES III)

Cook Group

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: drug eluting coronary stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00225693

578

Details and patient eligibility

About

The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.

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 given 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, an IVUS examination and 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 any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind