Text Size

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
History of Changes
  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:

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

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

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 May 16, 2013