Status:
COMPLETED
V-Flex Plus PTX Drug Eluting Coronary Stent
Lead Sponsor:
Cook Group Incorporated
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.
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 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00225693
Start Date
October 1 2003
End Date
July 1 2005
Last Update
February 1 2012
Active Locations (1)
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1
Contact Sponsor
Bloomington, Indiana, United States