Peripheral Arterial disease
Conditions
Interventions
None listed
Sponsors
Kameda Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects has symptomatic peripheral arterial disease of Rutherford category 2-5 2. Subject has a de novo or restenotic lesion with severer than 70% stenosis documented angiographically and no prior stent in the target lesion 3. Target lesion is limited at superficial femoral artery and does not exceed the medial femoral epicondyle or popliteal artery 4. Patency of at least 1 infrapopliteal artery to the ankle in continuity with the native femoropopliteal artery 5. A guidewire has successfully traversed the target treatment
Exclusion criteria
Exclusion criteria: 1. Subjects who rejected to participate this study through Opt-out method applied by a poster 2. Life expectancy <12 months 3. Pregnancy, suspected pregnancy, or breastfeeding during study period 4. Presence of cerebrovascular accident or myocardial infarction within 1 month of procedure 5. Untreated external iliac artery inflow lesion 6. Acute occlusive intraluminal thrombosis of the proposed lesion site. 7. Evidence of an aneurysm at the target lesion site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite outcomes of restenosis(defined as 20% or greater decrease in the ankle brachial index), clinical driven target lesion revascularization, or unplanned lower extremity major amputation at 12 months after interventions | — |
Secondary
| Measure | Time frame |
|---|---|
| all cause death, clinical driven target lesion revascularization, unplanned lower extremity major amputation, ankle brachial index, and peak systolic velocity ratio from duplex ultrasound at 6, 12, 24, 36 months after interventions | — |
Countries
Japan
Contacts
Public ContactDaisuke Ueshima
Kameda Medical Center Cardiology
Outcome results
None listed