Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion
Recruiting
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: Chocolate balloon
- 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
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
- Arm && Interventions
Group Intervention Description Chocolate balloon Chocolate balloon - Conventional ballon Chocolate balloon -
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Xuanwu Hospital
🇨🇳Beijing, None Selected, China