Concept Medical has announced the enrolment of the first patient in the FUTURE BTK (Randomised controlled trial of first sirolimus-coated balloon versus standard balloon angioplasty in the treatment of below-the-knee artery disease) trial. The index patient was successfully enrolled on 26 August 2020 in Singapore.
FUTURE BTK is a randomised, double-blind, placebo-controlled, multicentere trial. It is aimed at determining the effectiveness of MagicTouch PTA sirolimus-coated balloon versus standard balloon angioplasty for the treatment of below the knee arterial disease in chronic limb-threatening ischaemia (CLTI) patients.
Sirolimus-coated balloons are considered to be the next new generation of drug-coated balloons (DCBs), and MagicTouch PTA sirolimus-coated balloon offers a solution which optimises both the deliverability and the absorption of sirolimus into the vessel wall.
Edward Choke (Sengkang General Hospital, Singapore, Singapore), principal investigator of FUTURE-BTK comments: “CLTI is a condition which puts patients at an increased risk of limb amputation and death. Its burden is likely to grow in the coming years given the rising trends in key risk factors such as age and diabetes. Effective revascularisation is the cornerstone of treatment, but this is often hampered by high rates of restenosis and reintervention after conventional balloon angioplasty”.
He adds: “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 CLTI patients, and this will hopefully bring us closer to our goal of reducing leg amputations”.
The trial will enrol 210 patients with Rutherford class 4 to 6 CLTI. These subjects will be randomised in 2:1 fashion to receive either MagicTouch 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.