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

Not Applicable

Withdrawn

• Conditions: Ischemia; Atherosclerosis
• Interventions: Device: Excimer Laser Ablation Combined Drug-coated Balloon; Device: Drug-eluting Stent

• Registration Number: NCT05575245
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Study Start: 2022-03-03
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-10-09
• Study First Posted: 2022-10-12
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-04
• Last Update Posted: 2022-12-07
• Primary Completion: 2024-10-20
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Excimer Laser Ablation Combined Drug-coated Balloon	Excimer Laser Ablation Combined Drug-coated Balloon	Excimer Laser Ablation Combined Drug-coated Balloon group
Intervention: Drug-eluting Stent	Drug-eluting Stent	Drug-eluting Stent group

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
12-month Limb Salvage Rate	12 months	Limb Salvage is defined as the freedom from secondary major amputation
freedom from clinically-driven TLR	1 day	it is defined as the freedom 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,

Trial Locations

Locations (1)

Gu Yong Quan; 🇨🇳 Beijing, Beijing, China