The trial will evaluate the effectiveness of MagicTouch PTA sirolimus coated balloon versus standard balloon angioplasty to treat below the knee arterial disease in critical limb ischemia patients
Concept Medical has commenced the patient enrolment in the multi-centre trial, which is designed to evaluate the efficacy of MagicTouch PTA sirolimus coated balloon to treat below the knee (BTK) peripheral artery disease.
The first patient has been enroled in the FUTURE BTK trial (randomised controlled trial of first sirolimus coated balloon versus standard balloon angioplasty in the treatment of below the knee artery disease).
FUTURE BTK, a randomised, double-blind and placebo-controlled, will assess the effectiveness of MagicTouch PTA sirolimus coated balloon versus standard balloon angioplasty to treat below the knee arterial disease in critical limb ischemia (CLI) patients.
Concept Medical will recruit 210 patients in the trial
Concept Medical will recruit 210 patients with Rutherford class-4 to -6 CLI in the study. It will randomise the subjects in 2:1 ration to secure either MagicTouch PTA or standard balloon angioplasty.
The primary patency at six months is the primary outcome of the study, said the company. The patients will be monitored for up to two years.
According to the company, sirolimus coated balloons are regarded as the next-generation drug-coated balloons (DCBs).
MagicTouch PTA sirolimus coated balloon delivers a solution, which improves both the deliverability and the absorption of sirolimus into the vessel wall.
The principal investigator of the study is associate professor Edward Choke from the department of general surgery (Vascular Surgery) at the Sengkang General Hospital, Singapore.
Choke said: “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.
“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 randomised 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.”
In August 2019, Concept Medical secured breakthrough device designation from the US Food and Drug Administration (FDA) for its MagicTouch AVF sirolimus DCB.