Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis
NCT ID: NCT01558531
Last Updated: 2015-02-03
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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SUSPENDED
44 participants
OBSERVATIONAL
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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DEB
paclitaxel-eluting balloon angioplasty
DEB
paclitaxel-eluting balloon angioplasty
conventional PTA
historical conventional balloon angioplasty control group (patients referred to our institution between 2008 and 2009)
POBA
conventional balloon angioplasty
Interventions
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DEB
paclitaxel-eluting balloon angioplasty
POBA
conventional balloon angioplasty
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, previously treated with nitinol stent implantation, with 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
* need for amputation
* angiographic evidence of stent fracture
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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Grotti S, Liistro F, Angioli P, Ducci K, Falsini G, Porto I, Ricci L, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: Three-Year Results of the DEBATE-ISR Study. J Endovasc Ther. 2016 Feb;23(1):52-7. doi: 10.1177/1526602815614555. Epub 2015 Oct 28.
Liistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014 Feb;21(1):1-8. doi: 10.1583/13-4420R.1.
Other Identifiers
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Arezzo006
Identifier Type: -
Identifier Source: org_study_id
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