Status:
COMPLETED
The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial
Lead Sponsor:
Cook Group Incorporated
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
End Date :
August 1 2001
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00196079
Start Date
February 1 2000
End Date
August 1 2001
Last Update
February 1 2012
Active Locations (1)
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1
Contact Sponsor
Bloomington, Indiana, United States