Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation (DEBATE-BTK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT01558505
First received: March 17, 2012
Last updated: January 26, 2013
Last verified: January 2013
  Purpose

Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.


Condition Intervention Phase
Critical Limb Ischemia
Device: PEB
Device: POBA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study

Resource links provided by NLM:


Further study details as provided by Ospedale San Donato:

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


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

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

  • vessel reocclusion [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    incidence of vessel reocclusion


Enrollment: 142
Study Start Date: November 2010
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard PTA
conventional balloon angioplasty
Device: POBA
conventional balloon angioplasty
Experimental: Drug-eluting balloon angioplasty
paclitaxel-eluting balloon angioplasty
Device: PEB
paclitaxel-eluting balloon angioplasty

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age>18 years
  • angiographic stenosis>50% or occlusion of one below-knee vessel

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558505

Locations
Italy
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: NCT01558505     History of Changes
Other Study ID Numbers: Arezzo005
Study First Received: March 17, 2012
Last Updated: January 26, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale San Donato:
critical limb ischemia
drug-eluting balloon
restenosis

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014