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Clinical Trial Summary

This is a Pivotal, Prospective, randomised, two arm, placebo controlled, single-blind, multicentre trial that will be conducted at approximately 70 sites; approx. 40 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Singapore, Australia and Japan. Each site will be capped at 30 maximum subjects recruited. The main goal of this clinical trial is to determine the effectiveness and safety of the sirolimus drug coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of below the knee arterial disease. Eligible subjects will be randomised in a 1:1 allocation ratio and stratified by recruiting countries. Each subject will be randomized to receive either: 1. MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or 2. Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA).


Clinical Trial Description

The burden of limb loss because of peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by many vascular centres. In recent years, studies have shown that local drug delivery using drug coated balloons (DCB) during angioplasty for PAD can successfully deliver effective local tissue concentrations of antiproliferative drugs to the lesions in the artery involved in the PAD. This offers the potential for sustained anti-restenotic efficacy. Randomized trials have shown superiority of Paclitaxel DCBs over just plain-balloon angioplasty for treatment of femoropopliteal occlusive disease, and DCB is now considered the standard of care in many regions. However, the efficacy of Paclitaxel below the knee is less clear, as multiple randomized trials evaluating Paclitaxel-coated DCBs below the knee have failed to meet their primary endpoints. Alternative drugs for DCBs are therefore needed and sirolimus may offer an attractive alternative. Compared to Paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety. It has a high transfer rate to the vessel wall and has been shown to effectively inhibit neointimal hyperplasia in the porcine coronary model. In the coronary artery interventions, preliminary clinical studies using Sirolimus DCBs have also shown excellent procedural and 6- & 12- months patency. This study aims to conduct a single blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty in patients with below the knee arterial disease. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06182397
Study type Interventional
Source Concept Medical Inc.
Contact Farhana Siddique
Phone +919725495366
Email farhana@conceptmedical.com
Status Not yet recruiting
Phase N/A
Start date July 1, 2024
Completion date February 1, 2031

See also
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Recruiting NCT06211127 - Safety and Efficacy of Cold Laser Plaque Ablation for Lower Limb Arterial Stenosis and Occlusive Lesions N/A
Recruiting NCT04562740 - ABLUMINUS DES BTK Registry - FIM N/A
Recruiting NCT05054764 - Promus PREMIER Below The Knee Registry
Recruiting NCT04511247 - SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease N/A