Coronary Artery Disease
Conditions
Keywords
coronary artery, stenosis, drug eluting stent, stent
Brief summary
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.
Interventions
DEVICECoronary stent
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic in-stent % diameter at follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse events | — |
| Total lesion revascularization | — |
Countries
United States
Outcome results
None listed