NCT03638115

The VaSecure BTK Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Vascuros Medical Pte Ltd · Industry
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
DEVICE	VaSecure™	Drug Coated PTA Balloon Catheter

Timeline

• Start date: 2018-10-30
• Primary completion: 2019-06-01
• Completion: 2020-06-30
• First posted: 2018-08-20
• Last updated: 2018-10-26

Locations

7 sites across 3 countries: Belgium, Germany, Singapore