September 14, 2020
FUTURE SFA Trial of Concept Medical’s MagicTouch Sirolimus-Coated Balloon Commences Enrollment
September 14, 2020—Concept Medical, Inc. announced the commencement of enrollment in the FUTURE SFA randomized, double-blind, placebo-controlled, multicenter trial. The index patient was enrolled in Singapore on September 11.
FUTURE SFA will seek to determine the effectiveness of percutaneous transluminal angioplasty (PTA) with the company’s MagicTouch sirolimus-coated balloon compared with standard balloon angioplasty in the treatment of peripheral artery disease (PAD) in the superficial femoral artery and popliteal artery.
According to the company, the trial will enroll 153 patients with Rutherford class 3 to 6 PAD. These patients will be randomized 2:1 to receive either Magic Touch PTA or standard balloon angioplasty. The primary outcome will be primary patency at 6 months, defined as duplex peak systolic velocity ratio ≤ 2.4. The patients will be followed-up for 2 years.
The company noted that the trial is designed to follow a rigorous blinding protocol to minimize bias. Patients, care providers, investigators, and outcome assessors, including vascular technologists performing the duplex ultrasound, will be blinded to the treatment allocations.
The Principal Investigator of FUTURE SFA is Associate Professor Edward Choke, MBBS, with the Department of General Surgery (Vascular Surgery) at the Sengkang General Hospital in Singapore.
“I am inspired by the bold, imaginative, and futuristic concepts presented by the Nanolute technology of the MagicTouch PTA sirolimus-coated balloon,” commented Prof. Choke in Concept Medical’s press release. “In contrast to other contemporary technologies, MagicTouch PTA offers a solution which optimizes both the deliverability and the absorption of sirolimus into the vessel wall.”
Prof. Choke continued, “Initial experience with the XTOSI first-in-man study suggested that MagicTouch PTA can provide an effective way of revascularization for PAD patients by keeping the vessels open longer and reducing the need of repeated angioplasty procedures.”
He added, “I look forward to the FUTURE SFA randomized controlled trial, which will test whether the Magic Touch PTA sirolimus-coated balloon can improve the patencies of femoral and popliteal arteries in PAD patients. We hope to establish whether sirolimus-coated balloons will emerge as the new standard of care, which will impact the way we treat PAD.”
On August 27, Concept Medical announced the start of the FUTURE BTK trial of the MagicTouch in the treatment of below-the-knee artery disease in patients with critical limb ischemia.