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Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix

Primary Purpose

Peripheral Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Freeway PTA
Lutonix PTA
Sponsored by
Ospedale San Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

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.DonatoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Freeway

Lutonix

Arm Description

angioplasty with Freeway drug-eluting balloon

angioplasty with Lutonix drug-eluting balloon

Outcomes

Primary Outcome Measures

number of events of angiographic binary restenosis
number of events of angiographic binary restenosis

Secondary Outcome Measures

number of events of target lesion revascularization
number of events of target lesion revascularization
number of events of death
number of events of death
frequency of major amputation
frequency of major amputation

Full Information

First Posted
October 28, 2014
Last Updated
October 31, 2014
Sponsor
Ospedale San Donato
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1. Study Identification

Unique Protocol Identification Number
NCT02279784
Brief Title
Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Donato

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare in patients with critical limb ischemia the efficacy of angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in terms of restenosis.
Detailed Description
Two devices will be evaluated: the Lutonix and the Freeway paclitaxel eluting balloons. A post-hoc analysis will compare the results with the historical data from DEBATE-BTK (NCT01558505).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Freeway
Arm Type
Experimental
Arm Description
angioplasty with Freeway drug-eluting balloon
Arm Title
Lutonix
Arm Type
Experimental
Arm Description
angioplasty with Lutonix drug-eluting balloon
Intervention Type
Device
Intervention Name(s)
Freeway PTA
Intervention Description
angioplasty with Freeway drug-eluting balloon
Intervention Type
Device
Intervention Name(s)
Lutonix PTA
Intervention Description
angioplasty with Lutonix drug-eluting balloon
Primary Outcome Measure Information:
Title
number of events of angiographic binary restenosis
Description
number of events of angiographic binary restenosis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
number of events of target lesion revascularization
Description
number of events of target lesion revascularization
Time Frame
12 months
Title
number of events of death
Description
number of events of death
Time Frame
12 months
Title
frequency of major amputation
Description
frequency of major amputation
Time Frame
12 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Liistro, MD
Email
francescoliistro@hotmail.com
First Name & Middle Initial & Last Name & Degree
Leonardo Bolognese, MD, FESC
First Name & Middle Initial & Last Name & Degree
Giovanni Falsini, MD
First Name & Middle Initial & Last Name & Degree
Paolo Angioli, MD
First Name & Middle Initial & Last Name & Degree
Kenneth Ducci, MD
First Name & Middle Initial & Last Name & Degree
Francesco Liistro, MD
First Name & Middle Initial & Last Name & Degree
Simone Grotti, MD

12. IPD Sharing Statement

Learn more about this trial

Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix

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