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

NCT ID: NCT05575245

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2024-10-20

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.

Conditions

Atherosclerosis; Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention: Drug-eluting Stent

Drug-eluting Stent group

Group Type: ACTIVE_COMPARATOR

Drug-eluting Stent

Intervention Type: DEVICE

Drug-eluting Stent angioplasty

Intervention: Excimer Laser Ablation Combined Drug-coated Balloon

Excimer Laser Ablation Combined Drug-coated Balloon group

Group Type: EXPERIMENTAL

Excimer Laser Ablation Combined Drug-coated Balloon

Intervention Type: DEVICE

Excimer Laser Ablation Combined Drug-coated Balloon angioplasty

Interventions

Drug-eluting Stent

Drug-eluting Stent angioplasty

Intervention Type: DEVICE

Excimer Laser Ablation Combined Drug-coated Balloon

Excimer Laser Ablation Combined Drug-coated Balloon angioplasty

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gu Yong Quan

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

XuanwuH135

Identifier Type: -

Identifier Source: org_study_id