Peripheral Artery Disease
Conditions
Brief summary
The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.
Interventions
Sponsors
Ospedale San Donato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age\>18 years * critical limb ischemia (Rutherford class 4-6) * angiographic stenosis\>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled
Exclusion criteria
* need for major amputation known before intervention * allergy to Paclitaxel * contraindication for combined antiplatelet treatment * life expectancy \<1 year * hypersensitivity or contraindication to one of the study drugs * lack of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Lumen Loss (LLL) in the target lesion documented by angiography | 6 months | Late Lumen Loss (LLL) in the target lesion documented by angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of events of angiographic occlusive restenosis | 6 months | number of events of angiographic occlusive restenosis |
| Number of events of target lesion revascularization (TLR) | 12 months | number of events of target lesion revascularization |
Countries
Italy
Outcome results
None listed