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

Primary Purpose

Critical Limb Ischemia

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
PEB
POBA
Sponsored by
Leonardo Bolognese, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring critical limb ischemia, drug-eluting balloon, restenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Department, Ospedale S.Donato

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard PTA

Drug-eluting balloon angioplasty

Arm Description

conventional balloon angioplasty

paclitaxel-eluting balloon angioplasty

Outcomes

Primary Outcome Measures

angiographic binary restenosis
incidence of binary restenosis

Secondary Outcome Measures

major amputation
incidence of major amputation
target lesion revascularization
incidence of target lesion revascularization
vessel reocclusion
incidence of vessel reocclusion

Full Information

First Posted
March 17, 2012
Last Updated
January 26, 2013
Sponsor
Leonardo Bolognese, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01558505
Brief Title
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation
Acronym
DEBATE-BTK
Official Title
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leonardo Bolognese, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
Keywords
critical limb ischemia, drug-eluting balloon, restenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard PTA
Arm Type
Active Comparator
Arm Description
conventional balloon angioplasty
Arm Title
Drug-eluting balloon angioplasty
Arm Type
Experimental
Arm Description
paclitaxel-eluting balloon angioplasty
Intervention Type
Device
Intervention Name(s)
PEB
Intervention Description
paclitaxel-eluting balloon angioplasty
Intervention Type
Device
Intervention Name(s)
POBA
Intervention Description
conventional balloon angioplasty
Primary Outcome Measure Information:
Title
angiographic binary restenosis
Description
incidence of binary restenosis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
major amputation
Description
incidence of major amputation
Time Frame
24 motnhs
Title
target lesion revascularization
Description
incidence of target lesion revascularization
Time Frame
24 months
Title
vessel reocclusion
Description
incidence of vessel reocclusion
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cardiovascular Department, Ospedale S.Donato
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23797811
Citation
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. doi: 10.1161/CIRCULATIONAHA.113.001811.
Results Reference
derived

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Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation

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