Effects of antiplatelet drugs for coronary endothelial functions after drug-eluting stent placement
Phase 4
- Conditions
- Patients, complicated with peripheral arterial occlusive disease, without in-stent stenosis eight months after drug-eluting stent implantation in the left anterior descending coronary
- Registration Number
- JPRN-UMIN000009629
- Lead Sponsor
- The Institute of Health Biosciences, The University of Tokushima Graduate School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Subjects who fall under any of the following criteria will be excluded from this study 1. Patients with bleeding or bleeding tendency 2. Patients treated with antiplatelet drugs is not appropriate 3. Patients with a history of hypersensitivity or side effects caused by the study drugs 4. Patients with malapposition on OCT image 5. Patients without visible coating on stent surface on OCT image 6. Patients otherwise judged by the investigator to be inappropriate for inclusion in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. At the start of the study and eight months later, evaluation of either presence or absence of in-stent stenosis in left anterior descending coronary, judging whether new stenotic lesion exists in the left anterior descending coronary by angiography, and determination of stenosis rate by QCA 2. At the start of the study and eight months later, evaluation of vascular reactivity within 20 mm from distal end of in-stent in left anterior descending coronary by load test using acetylcholine and determination of average vessel diameter by QCA 3. At the start of the study and eight months later, evaluation of degree of in-stent intimal thickening (neo-intimal volume %) in left anterior descending coronary by OCT
- Secondary Outcome Measures
Name Time Method 1. At the start of the study and eight months later, judging whether new stenotic lesion exists in left circumflex coronary by angiography and determination of stenosis rate by QCA 2. At the start of the study and eight months later, evaluation of vascular reactivity within 20 mm from bifurcation of left circumflex coronary artery, or within 20 mm from distal end of in-stent in left anterior descending coronary in case of stent implanted in the range of evaluation, by load test using acetylcholine, and determination of average vessel diameter by QCA