PAD Clinical Trial
Official title:
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
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.
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.
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