The primary purpose of this study is to assess safety and efficacy of the Drug Eluting Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic obstructive vascular disease in patients presenting with long lesions. As secondary aim this study is going to explore treatment effect on a number of procedural and clinical endpoints in order to collect information to design a future comparative effectiveness study.
The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Eluting Balloon (DEB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions. The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DEB currently available on the market.
Study Type
OBSERVATIONAL
Enrollment
105
Anthea Hospital
Bari, Bari, Italy
Maria Cecilia Hospital
Cotignola, Ravenna, Italy
Città di Lecce Hospital
Lecce, Italy
Maria Eleonora Hospital, GVM Care & Research
Palermo, Italy
rate of primary patency
Primary patency is defined as freedom from the combined endpoints of clinically-driven target lesion revascularization (TLR) and \>50% restenosis in the treated lesion. Clinically driven TLR is defined as any re-intervention within the target lesion due to symptoms or drop of ABI of ≥20% or \>0.15 when compared to post-procedure. Restenosis \> 50% is defined by a peak systolic velocity ratio (PSVR) \> 2.4.
Time frame: within the first 12 months after percutaneous treatment
composite of all Major Adverse Events (MAE)
evaluate the incidence of the composite of all Major Adverse Events (MAE) through 24 months i.e. the first occurrence of any of the following: death from any cause, major target limb amputation, thrombosis at the target lesion site
Time frame: within the first 24 months after percutaneous treatment
incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE)
to assess the incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE) individual components through 24 months
Time frame: within the first 24 months after percutaneous treatment
clinical improvement as assessed by Rutherford Class changes
compare clinical improvement as assessed by Rutherford Class changes at 6, 12 and 24 months with respect to baseline
Time frame: within 6, 12 and 24 months vs baseline
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ICLAS Rapallo
Rapallo, Italy
Maria Pia Hospital
Torino, Italy