Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion

Recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT05894460
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them with conventional balloons.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-08
• Study Start: 2023-06-27
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

• Rutherford classification of 2-6 in patients with femoropopliteal atherosclerotic occlusive disease;
• primary cases with no previous surgical treatment of the target lesion;
• presence of at least one vessel with patency in the distal outflow tract;
• survival >1 year.

Exclusion Criteria

• planned stenting;
• presence of flow-limiting dissection prior to application of Chocolate balloon and conventional balloon dilation of the target lesion;
• combination of severe organ dysfunction of the heart, lungs and brain that cannot tolerate the procedure;
• allergy to contrast agents, anaesthetic drugs, anticoagulants and anti-platelet drugs;
• ineffective recanalization attempts;
• lesions within or adjacent to the aneurysm, or the presence of a popliteal aneurysm.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary patency	12 months	No occlusion or restenosis (\>50%) of the target vessel in the treated segment during follow-up and no further intervention is required.

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, None Selected, China