MAGICAL BTK Comparing Sirolimus Coated Balloon versus Standard Balloon Angioplasty for Treating Below-The-Knee Arterial Disease

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a sirolimus drug coated balloon compared to standard balloon angioplasty for treating below the knee arterial disease. This pivotal, prospective, randomized, two-arm, placebo-controlled trial will be conducted at about 80 sites worldwide, including the USA, Europe, Australia, and Asia. The study addresses the high burden of limb loss caused by peripheral arterial disease and explores sirolimus as an alternative to paclitaxel for drug coated balloons below the knee. Participants will be randomly assigned in equal groups to receive either the MagicTouch PTA sirolimus coated balloon catheter plus standard balloon angioplasty or a placebo balloon angioplasty plus standard balloon angioplasty. All patients first receive pre-dilation with a standard balloon angioplasty. The sirolimus coated balloon is used as an additional treatment after successful lesion preparation. The trial is single-blind and multicenter, aiming to compare outcomes between these two treated groups. During the study, participants will undergo assessments including angiographic evaluations and monitoring of limb health. The primary outcome is primary patency at 12 months, defined by freedom from vessel occlusion, restenosis, target lesion revascularization, and major amputation. Safety will also be evaluated at 6 months and 30 days with composite endpoints. Secondary outcomes include various safety and efficacy measurements up to 60 months. This comprehensive follow-up will help assess long-term treatment effects and participant safety throughout the study period.

Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease