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

NCT ID: NCT05894460

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

254 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-27

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chocolate balloon

Chocolate balloon

Intervention Type DEVICE

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

Conventional ballon

Chocolate balloon

Intervention Type DEVICE

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

Interventions

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Chocolate balloon

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital

Beijing, None Selected, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhu Tong

Role: primary

13522419980

Other Identifiers

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Chocolate-FP

Identifier Type: -

Identifier Source: org_study_id

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