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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01558531
Recruitment Status : Suspended (slow enrollment)
First Posted : March 20, 2012
Last Update Posted : February 3, 2015
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato

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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Device: DEB Device: POBA

Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study
Study Start Date : January 2010
Actual Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. angiographic binary re-restenosis [ Time Frame: 12 months ]
    incidence of angiographic binary re-restenosis

Secondary Outcome Measures :
  1. major amputation [ Time Frame: 24 months ]
    incidence of major amputation

  2. stent thrombosis [ Time Frame: 24 months ]
    incidence of stent thrombosis

  3. target lesion revascularization [ Time Frame: 24 months ]
    incidence of target lesion revascularization

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01558531

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato Identifier: NCT01558531     History of Changes
Other Study ID Numbers: Arezzo006
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015

Keywords provided by Leonardo Bolognese, MD, 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