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

This study has suspended participant recruitment.
(slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT01558531
First received: March 17, 2012
Last updated: October 20, 2012
Last verified: October 2012
  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 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
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
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
restenosis

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

ClinicalTrials.gov processed this record on July 20, 2014