Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity

Capital Medical University

Status

Withdrawn

Conditions

Ischemia

Atherosclerosis

Treatments

Device: Excimer Laser Ablation Combined Drug-coated Balloon

Device: Drug-eluting Stent

Study type

Interventional

Funder types

Other

Identifiers

NCT05575245

XuanwuH135

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria： 1.all patients signed an informed consent form; 2.digital subtraction angiography (DSA) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (Rutherford clinical category-Becker class II-III2-3) or critical limb ischemia (CLI) (Rutherford clinical category 4-5-Becker class IV-V) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up.

Exclusion criteria: 1. Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. Severe calcified lesions （grade 4 in the PACSS scale）; 3. In-stent restenosis lesion or surgical arterial bypass grafting; 4. Severe renal insufficiency: creatinine level greater than 2.5 mg/dL; 5. Platelet count below 100,000/μL or with antiplatelet / anticoagulation contraindications; 6. Immunologic diseases or malignant diseases; 7. Ongoing active infection; 8. Decompensated congestive heart failure or acute coronary syndrome; 9. Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.