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Drug Eluting Balloon in peripherAl inTErvention SFA (DEBATE SFA)

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
nitinol stent implantation
Sponsored by
Leonardo Bolognese, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring peripheral arterial disease, drug-eluting balloon, restenosis

Eligibility Criteria

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

Inclusion Criteria:

  • age>18 years
  • intermittent claudication(Fontane III or IV)
  • angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm
  • at least one below-knee vessel to the ankle

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

Sites / Locations

  • Cardiovascular Department, Ospedale S.Donato

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard PTA

DEB

Arm Description

nitinol stent implantation

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

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 13, 2012
Last Updated
January 26, 2013
Sponsor
Leonardo Bolognese, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01556542
Brief Title
Drug Eluting Balloon in peripherAl inTErvention SFA
Acronym
DEBATE SFA
Official Title
Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA 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
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
peripheral arterial disease, 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
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard PTA
Arm Type
Active Comparator
Arm Description
nitinol stent implantation
Arm Title
DEB
Arm Type
Experimental
Arm Description
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
Intervention Type
Device
Intervention Name(s)
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
Intervention Description
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
Intervention Type
Device
Intervention Name(s)
nitinol stent implantation
Intervention Description
nitinol stent implantation
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 months
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 intermittent claudication(Fontane III or IV) angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm at least one below-knee vessel to the ankle 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Liistro, MD
Organizational Affiliation
Cardiovascular Department, San Donato Hospital, Arezzo, Italy
Official's Role
Principal Investigator
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
24239203
Citation
Liistro F, Grotti S, Porto I, Angioli P, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302. doi: 10.1016/j.jcin.2013.07.010. Epub 2013 Nov 13.
Results Reference
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Drug Eluting Balloon in peripherAl inTErvention SFA

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