Critical Limb Ischemia
Conditions
Keywords
critical limb ischemia, drug-eluting balloon, restenosis
Brief summary
Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.
Interventions
Sponsors
Leonardo Bolognese, MD
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 |
|---|---|---|
| angiographic binary restenosis | 12 months | incidence of binary restenosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| major amputation | 24 motnhs | incidence of major amputation |
| target lesion revascularization | 24 months | incidence of target lesion revascularization |
| vessel reocclusion | 24 months | incidence of vessel reocclusion |
Countries
Italy
Outcome results
None listed