The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

Cook Group

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: Coronary stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00196079

506

Details and patient eligibility

About

The ASPECT study is an Asian multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Cook Incorporated Paclitaxel Eluting Supra G 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 must have given signed informed consent.
Patient agrees to return at one month for an office visit to assess cardiovascular status and at 4-6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.

Exclusion criteria

Patient is less than 18 years old.
Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
The 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 that.
Patient is pregnant.
Patient has other medical condition that may cause the patient to be non-compliant with the protocol, confound the results or is associated with limited life expectancy.