Concept Medical has announced the enrolment of the first patient in the FUTURE SFA (Randomised controlled trial of first sirolimus coated balloon versus standard balloon angioplasty in the Treatment of superficial femoral artery and popliteal artery disease) study.
The index patient was successfully enrolled on 12 September in Singapore.
FUTURE SFA is a randomised, double blind, placebo-controlled, multicentre trial to determine the effectiveness of the MagicTouch PTA sirolimus drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal arterial disease.
Sirolimus-coated balloons are considered to be the next new generation of DCBs and the novel MagicTouch PTA sirolimus-coated balloon (SCB), has emerged as one of the most promising transcatheter technologies in preventing restenosis for diseased arteries.
The principal investigator of FUTURE SFA is Edward Choke (Sengkang General Hospital, Singapore), who comments: “I am inspired by the bold, imaginative, and futuristic concepts presented by the Nanolute technology of the MagicTouch PTA sirolimus-coated balloon. In contrast to other contemporary technologies, MagicTouch PTA offers a solution which optimises both the deliverability and the absorption of sirolimus into the vessel wall.”
He adds: “Initial experience with the XTOSI first in man study suggested that MagicTouch PTA can provide an effective way of revascularisation for PAD patients, by keeping the vessels open longer and reducing the need of repeated angioplasty procedures. I look forward to the FUTURE SFA randomised 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 SCB will emerge as the new standard of care which will impact the way we treat PAD.”
The trial will enrol 153 patients with Rutherford class 3 to 6 PAD. These subjects will be randomised in 2:1 fashion to receive either Magic Touch PTA or standard balloon angioplasty.
Primary outcome will be primary patency at six months, defined as duplex peak systolic velocity ratio (PSVR) of 2.4 or less.
The trial is designed to follow a rigorous blinding protocol in order to minimise bias. Patients, care providers, investigators and outcome assessors, including vascular technologists performing the duplex ultrasound, will be blinded to the treatment allocations. The patients will be followed up for two years.