Peripheral Artery Disease
Conditions
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).
Interventions
DEVICEFreeway PTA
angioplasty with Freeway drug-eluting balloon
DEVICELutonix PTA
angioplasty with Lutonix drug-eluting balloon
Sponsors
Ospedale San Donato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of events of angiographic binary restenosis | 12 months | number of events of angiographic binary restenosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of events of target lesion revascularization | 12 months | number of events of target lesion revascularization |
| number of events of death | 12 months | number of events of death |
| frequency of major amputation | 12 months | frequency of major amputation |
Countries
Italy
Outcome results
None listed