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 sirolimus into the vessel wall, with the company touting sirolimus coated balloons as the new generation of drug-coated balloons (DCBs).
“The novel MagicTouch PTA sirolimus coated balloon has emerged as one of the most promising transcatheter technologies in preventing restenosis for below-the-knee lesions,” Sengkang General Hospital’s Edward Choke, the principal investigator for the trial, said in a news release. “The earlier data on the efficacy of MagicTouch PTA from small studies are encouraging but these need to be confirmed or refuted. I look forward to the Future BTK randomized controlled trial, which will test whether the MagicTouch PTA sirolimus coated balloon can improve the patency of below the knee arteries in CLI patients, and this will hopefully bring us closer to our goal of reducing leg amputations.”