Status:
UNKNOWN
Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix
Lead Sponsor:
Ospedale San Donato
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 resteno...
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).
Eligibility Criteria
Inclusion
- age\>18 years
- angiographic stenosis\>50% or occlusion of one below-knee vessel
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT02279784
Start Date
October 1 2014
End Date
October 1 2016
Last Update
November 3 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100