Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation
NCT ID: NCT01558505
Last Updated: 2013-01-29
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
142 participants
INTERVENTIONAL
2010-11-30
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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standard PTA
conventional balloon angioplasty
POBA
conventional balloon angioplasty
Drug-eluting balloon angioplasty
paclitaxel-eluting balloon angioplasty
PEB
paclitaxel-eluting balloon angioplasty
Interventions
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PEB
paclitaxel-eluting balloon angioplasty
POBA
conventional balloon angioplasty
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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Leonardo Bolognese, MD
OTHER
Responsible Party
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Leonardo Bolognese, MD
Director
Locations
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Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy
Countries
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References
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Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811.
Other Identifiers
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Arezzo005
Identifier Type: -
Identifier Source: org_study_id
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