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: October 20, 2012
Last verified: October 2012

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: November 2010
Primary Completion Date: September 2012 (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
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

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: October 20, 2012
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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014