Concept Medical announced today that it enrolled the first patient in its Future BTK trial for its peripheral artery disease (PAD) treatment.
The first patient was enrolled in Singapore yesterday for the randomized, double-blind, placebo-controlled, multi-center trial for determining the effectiveness of the MagicTouch sirolimus coated balloon compared to standard balloon angioplasty in treating below the knee arterial disease in critical limb ischemia (CLI) patients.
Concept Medical’s trial is slated to enroll 210 patients with Rutherford class -4 to -6 CLI, with patients randomized in 2-to-1 fashion for receiving either MagicTouch PTA or standard balloon angioplasty. The primary outcome will be primary patency at six months, defined as duplex peak systolic velocity ratio (PSVR) of 2.4 or less. The patients will be followed up for two years.
MagicTouch PTA is designed to offer a solution optimizing both the deliverability and absorption of sirolim…