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Clinical Trials/NCT01558531
NCT01558531
Suspended
Not Applicable

Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study

Leonardo Bolognese, MD1 site in 1 country44 target enrollmentJanuary 2010
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ConditionsPeripheral Arterial Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
Leonardo Bolognese, MD
Enrollment
44
Locations
1
Primary Endpoint
angiographic binary re-restenosis
Status
Suspended
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 2011
Last Updated
11 years ago
Study Type
Observational
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
  • •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

  • •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
  • •angiographic evidence of stent fracture

Outcomes

Primary Outcomes

angiographic binary re-restenosis

Time Frame: 12 months

incidence of angiographic binary re-restenosis

Secondary Outcomes

  • major amputation(24 months)
  • stent thrombosis(24 months)
  • target lesion revascularization(24 months)

Study Sites (1)

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