August 27, 2020
Enrollment Commences in FUTURE BTK Trial of Concept Medical’s MagicTouch Sirolimus-Coated Balloon
August 27, 2020—Concept Medical Inc. announced the enrollment of the first patient in the randomized controlled FUTURE BTK trial of the company’s MagicTouch sirolimus-coated balloon for percutaneous transluminal angioplasty (PTA) versus standard balloon angioplasty in the treatment of below-the-knee (BTK) artery disease in patients with critical limb ischemia (CLI).
The trial’s first patient was successfully enrolled by Principal Investigator Edward Choke, MD, with the Sengkang General Hospital in Singapore, where he is Associate Professor in the Department of General Surgery (Vascular Surgery).
According to the company, FUTURE BTK is a randomized, double-blind, placebo-controlled, multicenter trial aimed at determining the effectiveness of the MagicTouch PTA device. The trial will enroll 210 patients with Rutherford class 4 to class 6 CLI who will be randomized 2:1 to receive either MagicTouch PTA or standard balloon angioplasty.
The trial’s primary outcome will be primary patency at 6 months, defined as duplex peak systolic velocity ratio ≤ 2.4. Patients will be followed-up for 2 years.
“CLI is a condition which puts patients at an increased risk of limb amputation and death,” commented Prof. Choke in Concept Medical’s announcement. “Its burden is likely to grow in the coming years given the rising trends in key risk factors such as age and diabetes. Effective revascularization is the cornerstone of treatment, but this is often hampered by high rates of restenosis and reintervention after conventional balloon angioplasty.”
Prof. Choke added, “The novel MagicTouch PTA sirolimus-coated balloon has emerged as one of the most promising transcatheter technologies in preventing restenosis for BTK 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 randomized controlled trial, which will test whether the MagicTouch PTA sirolimus-coated balloon can improve the patency of BTK arteries in CLI patients, and this will hopefully bring us closer to our goal of reducing leg amputations.”