Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion
NCT ID: NCT05894460
Last Updated: 2023-08-02
Study Results
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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UNKNOWN
254 participants
OBSERVATIONAL
2023-06-27
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chocolate balloon
Chocolate balloon
Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty
Conventional ballon
Chocolate balloon
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Xuanwu Hospital
Beijing, None Selected, China
Countries
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Facility Contacts
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Other Identifiers
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Chocolate-FP
Identifier Type: -
Identifier Source: org_study_id
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