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

Xuanwu Hospital, Beijing254 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

254

Conditions

Peripheral Arterial Disease

Interventions

Chocolate balloonDEVICE

Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xuanwu Hospital

Beijing, None Selected, China

RECRUITING

Outcomes

Primary Outcomes

Primary patency

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

Time frame: 12 months

Data from ClinicalTrials.gov

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