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

Capital Medical University

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: Chocolate balloon

Study type: Observational

Funder types: Other

Identifiers

NCT05894460

Chocolate-FP

Details and patient eligibility

About

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.

Enrollment: 254 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

254 participants in 2 patient groups

Chocolate balloon

Treatment:

Device: Chocolate balloon

Conventional ballon

Treatment:

Device: Chocolate balloon