Arterial Disease of Legs Clinical Trial
Official title:
Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
This is a randomised, placebo-controlled, single blind, multicentre trial. The main goal of this clinical trial is to determine the effectiveness (primary patency) and safety of the sirolimus DCB versus standard PTA for the treatment of below the knee arterial disease. Participants 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).
The burden of limb loss as a result of a peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb and a lot of vascular centers adopted angioplasty as a first line strategy of revascularisation over surgical procedures. Local drug delivery using DCB during angioplasty for PAD can successfully deliver effective local tissue concentrations of anti-proliferative drugs to the lesions in the artery involved in the PAD. Randomized trials have shown superiority of Paclitaxel DCBs over just plain-balloon angioplasty for treatment of PAD, and DCB is now considered the standard of care. However, the safety of paclitaxel based DCBs has been called into question by recent meta-analyses, so alternative drugs for DCBs are urgently needed and sirolimus offers 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 month 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. ;
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