In Stent ELUTES Study
Not Applicable
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00225680
- Lead Sponsor
- Cook Group Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Angiographic target vessel failure (TVF) at follow up
- Secondary Outcome Measures
Name Time Method Major adverse events Target lesion revascularization
Trial Locations
- Locations (1)
Contact Sponsor
🇺🇸Bloomington, Indiana, United States
Contact Sponsor🇺🇸Bloomington, Indiana, United States