Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

Not Applicable

Recruiting

• Conditions: Ischemia; Atherosclerosis
• Interventions: Device: balloon and Stent; Device: endovascular debulking and DCB

• Registration Number: NCT05158257
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions.

Detailed Description

Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the endovascular debulking combined drug-coated balloon group and balloon dilatation combined with stent angioplasty 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: 2021-09-30
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-09
• Last Update Posted: 2022-10-12
• Primary Completion: 2023-10-10
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: balloon and Stents	balloon and Stent	plain balloon and Stents group
Intervention: debulking and drug coated balloon	endovascular debulking and DCB	debulking and drug coated balloon 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
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
Technical success rate	1 day	Technical success was defined as residual stenosis less than 30% by final
freedom from clinically-driven TLR rate	12 months	it is defined as the freedom from clinically-driven target lesion revascularization

Trial Locations

Locations (1)

Gu Yong Quan; 🇨🇳 Beijing, Beijing, China