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
104 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
nitinol stent implantation
nitinol stent implantation
nitinol stent implantation
DEB
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
Interventions
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paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
nitinol stent implantation
nitinol stent implantation
Eligibility Criteria
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Inclusion Criteria
* intermittent claudication(Fontane III or IV)
* angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm
* at least one below-knee vessel to the ankle
Exclusion Criteria
* 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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Leonardo Bolognese, MD
OTHER
Responsible Party
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Leonardo Bolognese, MD
Director of Cardiovascular Department
Principal Investigators
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Francesco Liistro, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Department, San Donato Hospital, Arezzo, Italy
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, Grotti S, Porto I, Angioli P, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302. doi: 10.1016/j.jcin.2013.07.010. Epub 2013 Nov 13.
Other Identifiers
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Arezzo004
Identifier Type: -
Identifier Source: org_study_id
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