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

This study has suspended participant recruitment.
(slow enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558531
First Posted: March 20, 2012
Last Update Posted: February 3, 2015
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.
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
  Purpose
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 Leonardo Bolognese, MD, Ospedale San Donato:

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


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

  • stent thrombosis [ Time Frame: 24 months ]
    incidence of stent thrombosis

  • target lesion revascularization [ Time Frame: 24 months ]
    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
DEB
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referring to our institution for peripheral artery disease
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01558531


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

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
First Submitted: March 17, 2012
First Posted: March 20, 2012
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
restenosis

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