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

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ClinicalTrials.gov Identifier: NCT02279784
Recruitment Status : Unknown
Verified October 2014 by Leonardo Bolognese, MD, Ospedale San Donato.
Recruitment status was:  Recruiting
First Posted : October 31, 2014
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato

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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: Freeway PTA Device: Lutonix PTA Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Freeway
angioplasty with Freeway drug-eluting balloon
Device: Freeway PTA
angioplasty with Freeway drug-eluting balloon

Experimental: Lutonix
angioplasty with Lutonix drug-eluting balloon
Device: Lutonix PTA
angioplasty with Lutonix drug-eluting balloon




Primary Outcome Measures :
  1. number of events of angiographic binary restenosis [ Time Frame: 12 months ]
    number of events of angiographic binary restenosis


Secondary Outcome Measures :
  1. number of events of target lesion revascularization [ Time Frame: 12 months ]
    number of events of target lesion revascularization

  2. number of events of death [ Time Frame: 12 months ]
    number of events of death

  3. frequency of major amputation [ Time Frame: 12 months ]
    frequency of major amputation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279784


Locations
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Italy
Cardiovascular Department, Ospedale S.Donato Recruiting
Arezzo, AR, Italy, 52100
Contact: Francesco Liistro, MD       francescoliistro@hotmail.com   
Principal Investigator: Leonardo Bolognese, MD, FESC         
Sub-Investigator: Giovanni Falsini, MD         
Sub-Investigator: Paolo Angioli, MD         
Sub-Investigator: Kenneth Ducci, MD         
Principal Investigator: Francesco Liistro, MD         
Sub-Investigator: Simone Grotti, MD         
Sponsors and Collaborators
Ospedale San Donato

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Responsible Party: Leonardo Bolognese, MD, MD, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT02279784     History of Changes
Other Study ID Numbers: Arezzo013
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases