Clinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
- Conditions
- IschemiaAtherosclerosis
- Registration Number
- NCT02840786
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Brief Summary
This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
- Detailed Description
This is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 12-month Primary Patency Rate 12 months systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
- Secondary Outcome Measures
Name Time Method Technical success 1 day Technical success was defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.
freedom from clinically-driven TLR 12 months it is defined as thefreedom from clinically-driven target lesion revascularization
Major Adverse Events at 12-month Post Procedure 12 months Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization , and significant embolic events, which were defined as causing end-organ damage.
12-month Limb Salvage Rate 12 months Limb Salvage is defined as the freedom from secondary major amputation
Trial Locations
- Locations (1)
Gu Yong Quan
🇨🇳Beijing, Beijing, China
Gu Yong Quan🇨🇳Beijing, Beijing, China