Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04534257 - Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore N/A
Recruiting NCT04511234 - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Completed NCT02554266 - Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
Completed NCT03921905 - Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Not yet recruiting NCT05063474 - Microvascular Reactivity in Peripheral Artery Disease
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT02389023 - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery N/A
Completed NCT02563535 - Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia Phase 4
Completed NCT02542267 - In-Stent Restenosis Post-Approval Study N/A
Completed NCT02522884 - Tack Optimized Balloon Angioplasty Study of the Tack Endovascular Systemâ„¢ in Femoropoliteal Arteries N/A
Completed NCT02539940 - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Completed NCT02145065 - First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r) N/A
Completed NCT02228564 - BARD® Study of LIFESTREAMâ„¢ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease N/A
Completed NCT02262949 - A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System N/A
Completed NCT01743872 - Optical Imaging Measurement of Intravascular Solution Efficacy Trial N/A
Recruiting NCT01424020 - Walking Estimated Limitation Calculated by History - Study 2 Phase 4
Active, not recruiting NCT01597453 - NOR-SYS: The Norwegian Stroke in the Young Study N/A
Withdrawn NCT00569686 - Lovaza Therapy of Peripheral Arterial Disease N/A