Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis (DEBATE-ISR)

This study has suspended participant recruitment.
(slow enrollment)
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:
First received: March 17, 2012
Last updated: February 2, 2015
Last verified: February 2015
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.

Condition Intervention Phase
Peripheral Arterial Disease
Device: DEB
Device: POBA
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study

Resource links provided by NLM:

Further study details as provided by Ospedale San Donato:

Primary Outcome Measures:
  • angiographic binary re-restenosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    incidence of angiographic binary re-restenosis

Secondary Outcome Measures:
  • major amputation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    incidence of major amputation

  • stent thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    incidence of stent thrombosis

  • target lesion revascularization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    incidence of target lesion revascularization

Enrollment: 44
Study Start Date: January 2010
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
paclitaxel-eluting balloon angioplasty
Device: DEB
paclitaxel-eluting balloon angioplasty
conventional PTA
historical conventional balloon angioplasty control group (patients referred to our institution between 2008 and 2009)
Device: POBA
conventional balloon angioplasty


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referring to our institution for peripheral artery disease

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01558531

Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100
Sponsors and Collaborators
Leonardo Bolognese, MD
  More Information

No publications provided by Ospedale San Donato

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01558531     History of Changes
Other Study ID Numbers: Arezzo006 
Study First Received: March 17, 2012
Last Updated: February 2, 2015
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale San Donato:
peripheral arterial disease
drug-eluting balloon

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 04, 2016