Status:
COMPLETED
In Stent ELUTES Study
Lead Sponsor:
Cook Group Incorporated
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug Eluting coronary stent with conventional treatment for in-stent restenosis for coronary arteries.
Eligibility Criteria
Inclusion
- Patient has given informed consent
- Patient has target lesion in native coronary artery or coronary bypass graft
- Patient has in-stent restenosis \>60%
- Patient has reference artery diameter 2.7-3.5
- Patient agrees to return for clinical assessment at 1, 6, 9, 12 and 24 months and for a treadmill test at 9 months and an angiogram at 9 months and 24 months.
Exclusion
- Patient is less than 18 years of age
- Patient is pregnant or breast feeding
- Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Patient is simultaneously participating in another investigative interventional cardiovascular drug or device study.
- Patient has known hypersensitivity or contraindication to aspirin or stainless steel or a sensitivity to contrast agent.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00225680
Start Date
April 1 2002
End Date
August 1 2005
Last Update
February 1 2012
Active Locations (1)
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1
Contact Sponsor
Bloomington, Indiana, United States