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Clinical Trials/NCT02279784
NCT02279784
Unknown
Phase 4

Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix

Ospedale San Donato1 site in 1 country160 target enrollmentOctober 2014
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ConditionsPeripheral Artery Disease

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Peripheral Artery Disease
Sponsor
Ospedale San Donato
Enrollment
160
Locations
1
Primary Endpoint
number of events of angiographic binary restenosis
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of this study is to compare in patients with critical limb ischemia the efficacy of angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in terms of restenosis.

Detailed Description

Two devices will be evaluated: the Lutonix and the Freeway paclitaxel eluting balloons. A post-hoc analysis will compare the results with the historical data from DEBATE-BTK (NCT01558505).

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
October 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leonardo Bolognese, MD

MD

Ospedale San Donato

Eligibility Criteria

Inclusion Criteria

  • •age\>18 years
  • •angiographic stenosis\>50% or occlusion of one below-knee vessel

Exclusion Criteria

  • •allergy to Paclitaxel
  • •contraindication for combined antiplatelet treatment
  • •life expectancy \<1 year
  • •hypersensitivity or contraindication to one of the study drugs
  • •lack of consent
  • •need for amputation

Outcomes

Primary Outcomes

number of events of angiographic binary restenosis

Time Frame: 12 months

number of events of angiographic binary restenosis

Secondary Outcomes

  • frequency of major amputation(12 months)
  • number of events of target lesion revascularization(12 months)
  • number of events of death(12 months)

Study Sites (1)

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