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

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ClinicalTrials.gov Identifier: NCT01558505
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : January 29, 2013
Sponsor:
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

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



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

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): NCT01558505


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

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
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
restenosis

Additional relevant MeSH terms:
Ischemia
Pathologic Processes