DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia
NCT ID: NCT02750605
Last Updated: 2022-12-30
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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COMPLETED
NA
70 participants
INTERVENTIONAL
2016-02-29
2022-08-30
Brief Summary
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Results will be defined as:
Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.
Primary endpoints:
Primary Patency at 12 months, TLR (clinical driven),
Secondary endpoints:
Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Drug eluting balloon angioplasty
Intervention with DEB angioplasty in long lesions of crural arteries
DEB
Intervention with drug eluting balloon.
Plain old balloon angioplasty
Intervention with plain old balloon angioplasty POBA in long lesions of crural arteries
POBA
Intervention with old technology as comparison
Interventions
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DEB
Intervention with drug eluting balloon.
POBA
Intervention with old technology as comparison
Eligibility Criteria
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Inclusion Criteria
* Crural disease, long lesions, more than 2 cm.
* Life expectancy \> 1year
* \> 18 years
Exclusion Criteria
* Patients disapproval
* Allergy to drug or contrast
18 Years
ALL
No
Sponsors
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Skane University Hospital
OTHER
Responsible Party
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Torbjorn Fransson
Consultant, Vascular Surgery
Principal Investigators
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Torbjörn Fransson
Role: PRINCIPAL_INVESTIGATOR
SUS, Malmö
Locations
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Vascular center
Malmo, , Sweden
Countries
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Other Identifiers
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TF3
Identifier Type: -
Identifier Source: org_study_id