IntravasCular Imaging-Guided Versus AngiogRaphy-GUided Drug-Eluting Stent Implantation for Fermoropopliteal Artery Disease, A feasibility study
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0005057
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1.20 years of age=85 years of age.
2.Intermittent claudication or tissue loss suitable for elective endovascular intervention (Rutherford category 2,3,4, or 5)
3.Significant native superficial femoral or proximal popliteal artery lesions suitable for stent implantation(residual angiographic stenosis =70% ). Restenotic lesions can be enrolled at least 12-month after the index procedure uding plain balloon or drug-coated balloon.
4.Total lesion length of 30 to 220 mm
5.Reference vessel diameter of 4 – 6 mm
6.The patient or fuardian agrees written conenst to the study protocol.
1.Existence of a stent in the target vessel
2.Previous use of atherectomy device in the target vessel
3.Use of drug-coated balloon in the target vessel within 12-month
4.Significant stenosis or occlusion (diameter stenosis =70%) in all 3 infrapopliteal arteries
5.A known intolerance or contraindication to antiplatelet drugs (aspirin or clopidogrel)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method peak systolic velocity ratio(peak systolic velocity ratio at the proximal and the distal portion of the implanted stent.) of 2.4 or lower as assessed by the duplex ultrasound;procedure related death;major amputation of the target limb or target-lesion revascularization
- Secondary Outcome Measures
Name Time Method Technical success: deployment of the stent to the target lesion to achieve residual angiographic stenosis =30%;Procedural success: technical success without major adverse events