Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation
Phase 4
Completed
- Conditions
- Critical Limb Ischemia
- Interventions
- Device: POBADevice: PEB
- Registration Number
- NCT01558505
- Lead Sponsor
- Leonardo Bolognese, MD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard PTA POBA conventional balloon angioplasty Drug-eluting balloon angioplasty PEB paclitaxel-eluting balloon angioplasty
- Primary Outcome Measures
Name Time Method angiographic binary restenosis 12 months incidence of binary restenosis
- Secondary Outcome Measures
Name Time Method vessel reocclusion 24 months incidence of vessel reocclusion
target lesion revascularization 24 months incidence of target lesion revascularization
major amputation 24 motnhs incidence of major amputation
Trial Locations
- Locations (1)
Cardiovascular Department, Ospedale S.Donato
🇮🇹Arezzo, AR, Italy