None listed
Conditions
Interventions
Procedure/Surgery : In the IVUS-guided group, IVUS will be either automatically (1 mm/sec) or manually (5-10 mm/sec) pulled back at a constant speed according to the lesion length. Stent size and leng
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Technical success: deployment of the stent to the target lesion to achieve residual angiographic stenosis =30%;Procedural success: technical success without major adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactGU DA SEUL
Asan Medical Center
Outcome results
None listed