Prospective observational comparison study between endovascular treatment devices for femoropopliteal arterial disease
Not Applicable
Recruiting
- Conditions
- Peripheral Arterial disease
- Registration Number
- JPRN-UMIN000042918
- Lead Sponsor
- Kameda Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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