Drug Eluting Balloon (DEB) and Long Lesions of Superficial Femoral Artery (SFA) Ischemic Vascular Disease

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Safety and Efficacy of the Drug Eluting Balloon (DEB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With Long Lesions: a Pilot Study

Conditions
-----------------
Peripheral Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4; Target lesion consists of a single solitary or multiple adjacent de novo or restenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm; Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee); Life expectancy >1 year in the Investigator's opinion; Written informed consent. Exclusion criteria: Given the observational nature of the study, no study-specific but only clinical exclusion criteria will apply: Patient unwilling or unlikely to comply with FU schedule; Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure; Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel; Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure; 15 cm long inflow lesion (≥50% DS) or occlusion (any length) in the ipsilateral Iliac artery; Failure to successfully treat < 15 cm long inflow lesion in the ipsilateral Iliac artery
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within the first 12 months after percutaneous treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | within 6, 12 and 24 months vs baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Eluting Balloon (DEB) technology, long SFA lesions disease