V-Flex Plus PTX Drug Eluting Coronary Stent
Not Applicable
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00225693
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluation by IVUS of % diameter stenosis 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