Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

Not Applicable

Recruiting

• Conditions: Atherosclerosis; Ischemia
• Interventions: Device: plain balloon; Device: chocolate balloon

• Registration Number: NCT05158283
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions.

Detailed Description

Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the chocolate balloon group and plain balloon dilatation group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments.

Study Timeline

• Study Start: 2021-08-30
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-15
• Status Verified: 2022-10
• Primary Completion: 2022-10-01
• Last Update Submitted: 2022-10-09
• Last Update Posted: 2022-10-12
• Study Completion: 2022-12-01

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: plain balloon	plain balloon	plain balloon group
Intervention: Chocolate balloon	chocolate balloon	Chocolate 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
12-month Limb Salvage Rate	12 months	Limb Salvage is defined as the freedom from secondary major amputation
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.
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 thefreedom from clinically-driven target lesion revascularization

Trial Locations

Locations (1)

Gu Yong Quan; 🇨🇳 Beijing, Beijing, China