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Clinical Trials/NCT01558505
NCT01558505
Completed
Phase 4

Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study

Leonardo Bolognese, MD1 site in 1 country142 target enrollmentNovember 2010
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ConditionsCritical Limb Ischemia

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Critical Limb Ischemia
Sponsor
Leonardo Bolognese, MD
Enrollment
142
Locations
1
Primary Endpoint
angiographic binary restenosis
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
September 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Leonardo Bolognese, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Leonardo Bolognese, MD

Director

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

angiographic binary restenosis

Time Frame: 12 months

incidence of binary restenosis

Secondary Outcomes

  • target lesion revascularization(24 months)
  • major amputation(24 motnhs)
  • vessel reocclusion(24 months)

Study Sites (1)

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