Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions
NCT ID: NCT01969630
Last Updated: 2013-10-25
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
250 participants
INTERVENTIONAL
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PEB
PEB angioplasty plus provisional nitinol stent implantation
PEB
Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation
PES
Systematic PES angioplasty
PES
Systematic Paclitaxel eluting stent angioplasty
Interventions
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PEB
Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation
PES
Systematic Paclitaxel eluting stent angioplasty
Eligibility Criteria
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Inclusion Criteria
* de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries
* presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk
* presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis \>70%)
Exclusion Criteria
* contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel
* need for major amputation (MA) at the time of enrolment
* Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation
18 Years
ALL
No
Sponsors
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Ospedale San Donato
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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Facility Contacts
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Francesco Liistro, MD
Role: primary
References
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Liistro F, Angioli P, Porto I, Ducci K, Falsini G, Ventoruzzo G, Ricci L, Scatena A, Grotti S, Bolognese L. Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study. J Am Coll Cardiol. 2019 Jul 16;74(2):205-215. doi: 10.1016/j.jacc.2019.04.057.
Other Identifiers
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Arezzo011
Identifier Type: -
Identifier Source: org_study_id