FUTURE BTK: Randomized Controlled Trial of Sirolimus Drug Coated Balloon Versus Standard Balloon Angioplasty for Below The Knee Arterial Disease

What this Trial Is About

This research aims to evaluate and compare the use of a sirolimus drug coated balloon versus standard balloon angioplasty for treating below the knee arterial disease, a condition linked to peripheral arterial disease (PAD) that can lead to limb loss. The study addresses concerns about safety with current paclitaxel drug coated balloons and explores sirolimus as a potentially safer alternative with promising early results in coronary arteries. Participants will receive either the MagicTouch PTA sirolimus drug coated balloon after successful plain balloon angioplasty or a placebo balloon angioplasty alongside the standard procedure. The sirolimus balloon is sized according to the initial angioplasty and applied to the lesion. The study is randomized, double-blind, and involves multiple centers. Throughout the trial, participants will be monitored for primary patency at 6 months, along with secondary outcomes including death, limb amputation, vessel thrombosis, adverse events, procedural success, revascularization need, wound healing, and pressure assessments up to 24 months. The research includes detailed follow-ups and safety checks to assess the device and procedure effectiveness over time.

SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease