Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions

Study Overview
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Brief Summary
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The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Coated Balloon (DCB) 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) DCB currently available on the market.

Detailed Description
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The present study is designed as a prospective, open label, observational study. The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done. Patients elected for endovascular revascularization with DCB will be asked their written consent to the use of their personal data. Revascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days), 24 and 36 months (±30 days). Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.

Official Title
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Safety and Efficacy of the Drug Coated Balloon (DCB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With TASC C and D Lesions: a Pilot Study

Conditions
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PAD

Intervention / Treatment
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* Device: Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented obstructive 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 re-stenotic 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 popliteal artery (P1-2-3) Life expectancy >1 year in the Investigator's opinion Written informed consent Exclusion Criteria: 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) Failure to successfully treat < 15 cm long inflow lesion in the ipsilateral Iliac artery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Drug Coated Balloon|Peripheral PTA with a drug coated balloon|

What is the study measuring?
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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. | 12 months after percutaneous treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of all Major Adverse Events (MAE) | Incidence of the composite of all Major Adverse Events (MAE) through 24 months | 24 months after percutaneous treatment | 
| Incidence of Major Adverse Events (MAE) | Incidence of Major Adverse Events (MAE) through 36 months | 36 months after percutaneous treatment | 
| Clinical improvement as assessed by Rutherford Class changes | Clinical improvement as assessed by Rutherford Class changes | 6, 12, 24 and 36 months vs baseline |