Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix
NCT ID: NCT02279784
Last Updated: 2014-11-03
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
PHASE4
160 participants
INTERVENTIONAL
2014-10-31
2016-10-31
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
DOUBLE
Study Groups
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Freeway
angioplasty with Freeway drug-eluting balloon
Freeway PTA
angioplasty with Freeway drug-eluting balloon
Lutonix
angioplasty with Lutonix drug-eluting balloon
Lutonix PTA
angioplasty with Lutonix drug-eluting balloon
Interventions
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Freeway PTA
angioplasty with Freeway drug-eluting balloon
Lutonix PTA
angioplasty with Lutonix drug-eluting balloon
Eligibility Criteria
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Inclusion Criteria
* angiographic stenosis\>50% or occlusion of one below-knee vessel
Exclusion Criteria
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
* need for amputation
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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Facility Contacts
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Other Identifiers
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Arezzo013
Identifier Type: -
Identifier Source: org_study_id
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