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

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05894460

Collaborator

(none)

254

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Device: Chocolate balloon

Study Design

Study Type:

Observational

Anticipated Enrollment :

254 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion: a Single-centre, Prospective Observational Study

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Chocolate balloon	Device: Chocolate balloon Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty
Conventional ballon	Device: Chocolate balloon Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty

Arm

Intervention/Treatment

Chocolate balloon

Device: Chocolate balloon

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

Conventional ballon

Device: Chocolate balloon

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.