Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
NCT ID: NCT02563535
Last Updated: 2020-01-22
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
PHASE4
105 participants
INTERVENTIONAL
2015-09-30
2020-01-31
Brief Summary
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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 with Litos drug-eluting balloon
DEB
angioplasty with Litos drug eluting balloon
conventional PTA
angioplasty with conventional balloon
PTA
angioplasty with conventional balloon
Interventions
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DEB
angioplasty with Litos drug eluting balloon
PTA
angioplasty with conventional balloon
Eligibility Criteria
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Inclusion Criteria
* critical limb ischemia (Rutherford class 4-6)
* angiographic stenosis\>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled
Exclusion Criteria
* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
18 Years
ALL
No
Sponsors
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Ospedale San Donato
OTHER
Responsible Party
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Leonardo Bolognese, MD
MD
Locations
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Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy
Countries
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Other Identifiers
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Arezzo015
Identifier Type: -
Identifier Source: org_study_id
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