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

This study has been completed.
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato Identifier:
First received: March 17, 2012
Last updated: January 26, 2013
Last verified: January 2013
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Leonardo Bolognese, MD, Ospedale San Donato:

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

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

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

  • vessel reocclusion [ Time Frame: 24 months ]
    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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01558505

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato Identifier: NCT01558505     History of Changes
Other Study ID Numbers: Arezzo005
Study First Received: March 17, 2012
Last Updated: January 26, 2013

Keywords provided by Leonardo Bolognese, MD, Ospedale San Donato:
critical limb ischemia
drug-eluting balloon

Additional relevant MeSH terms:
Pathologic Processes processed this record on September 19, 2017