The VaSecure BTK Study

Status Recruiting

Clinical Trial Summary

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)

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03638115
Study type	Interventional
Source	Vascuros Medical Pte Ltd
Contact	Anthony Lie
Phone	+6569096493
Email	a.lie@vascuros.com
Status	Recruiting
Phase	N/A
Start date	October 30, 2018
Completion date	June 30, 2020

View Details

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