Peripheral Artery Disease Clinical Trial
Official title:
Clinical Investigation of the Safety & Effectiveness of the VaSecure 018 Drug Coated PTA Balloon Catheter in the Treatment of Patients With Chronic Limb Threatening Ischemia (CLTI) Involving Below-the-Knee (BTK) Arteries
To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)
The VaSecure Drug Coated PTA Balloon Catheter is indicated for percutaneous transluminal
angioplasty (PTA), after predilatation, of de novo lesions in the peripheral vasculature of
the lower limb with reference vessel diameters of 2-4 mm.
The study will include patients with lesions located in the infrapopliteal arteries diagnosed
with CLTI of Rutherford categories 3-5. A maximum number of 46 patients will be enrolled in
this clinical investigation in 7 sites in Europe and 2 in Singapore.
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