Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atherosclerosis
- Sponsor
- Xuanwu Hospital, Beijing
- Locations
- 1
- Primary Endpoint
- 12-month Primary Patency Rate
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.
Detailed Description
Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the Excimer Laser Ablation Combined Drug-coated Balloon group and drug-eluting stent group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. At the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
12-month Primary Patency Rate
Time Frame: 12 months
systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
Secondary Outcomes
- Technical success(1 day)
- 12-month Limb Salvage Rate(12 months)
- freedom from clinically-driven TLR(1 day)
- Major Adverse Events at 12-month Post Procedure(12 months)