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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.
 
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

Tracking Information
First Submitted Date  ICMJE March 17, 2012
First Posted Date  ICMJE March 20, 2012
Last Update Posted Date January 29, 2013
Study Start Date  ICMJE November 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2013)
angiographic binary restenosis [ Time Frame: 12 months ]
incidence of binary restenosis
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2012)
angiographic binary restenosis [ Time Frame: 24 months ]
incidence of binary restenosis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2012)
  • major amputation [ Time Frame: 24 motnhs ]
    incidence of major amputation
  • stent thrombosis [ Time Frame: 24 months ]
    incidence of stent thrombosis
  • target lesion revascularization [ Time Frame: 24 months ]
    incidence of target lesion revascularization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation
Official Title  ICMJE Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Critical Limb Ischemia
Intervention  ICMJE
  • Device: PEB
    paclitaxel-eluting balloon angioplasty
  • Device: POBA
    conventional balloon angioplasty
Study Arms  ICMJE
  • Active Comparator: standard PTA
    conventional balloon angioplasty
    Intervention: Device: POBA
  • Experimental: Drug-eluting balloon angioplasty
    paclitaxel-eluting balloon angioplasty
    Intervention: Device: PEB
Publications * Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2012)
142
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2012)
150
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01558505
Other Study ID Numbers  ICMJE Arezzo005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leonardo Bolognese, MD, Ospedale San Donato
Study Sponsor  ICMJE Leonardo Bolognese, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ospedale San Donato
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP