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

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: NCT01558505
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : January 29, 2013
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato

Brief Summary:
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 or disease Intervention/treatment Phase
Critical Limb Ischemia Device: PEB Device: POBA Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
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
Study Start Date : November 2010
Actual Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
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

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

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

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

  3. vessel reocclusion [ Time Frame: 24 months ]
    incidence of vessel reocclusion

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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): NCT01558505

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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):
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Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato Identifier: NCT01558505    
Other Study ID Numbers: Arezzo005
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013
Keywords provided by Leonardo Bolognese, MD, Ospedale San Donato:
critical limb ischemia
drug-eluting balloon
Additional relevant MeSH terms:
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Pathologic Processes