Concept Medical Inc. Announces First Patient Enrolled in FUTURE BTK Trial Evaluating MagicTouch PTA Sirolimus-Coated Balloon for Below-the-Knee Peripheral Artery Disease

SINGAPORE, Aug. 28, 2020 /PRNewswire/ -- Focused on vascular interventional drug delivery devicesConcept Medical Inc. announced that the company'sFUTURE BTK(The first randomized controlled trial comparing sirolimus-coated balloons with standard balloon angioplasty in the treatment of below-the-knee arterial disease) plans to enroll its first patient.

The index patient was successfully enrolled in Singapore on August 26, 2020.

FUTURE BTKis a randomized, double-blind, placebo-controlled, multicenter trial. This trial is designed to evaluate, in patients with critical limb ischemia (CLI) undergoing treatment for below-the-knee (BTK) arterial disease, compared with standard balloon angioplasty,MagicTouch PTAEfficacy of Sirolimus-Coated Balloons.

The treatment of severe limb ischemia mainly involves vascular reconstruction of arteries below the knee using angioplasty. During angioplasty, local drug delivery via drug-coated balloons (DCB) can successfully deliver medications targeting lesions in the arteries to prevent malignant cell proliferation and reduce the risk of postoperative restenosis.Sirolimus-Coated BalloonNow considered a new generation of drug-coated balloons, the MagicTouch PTA sirolimus-coated balloon offers a solution that optimizes the delivery and absorption of sirolimus into the vessel wall.

FUTURE-BTKThe principal investigator of the trial is Associate Professor Edward Choke from the Department of General Surgery (Vascular Surgery) at Sengkang General Hospital in Singapore.

Associate Professor Edward Choke stated, “Critical limb ischemia places patients at a higher risk of amputation and death. Given the upward trends in key risk factors such as age and diabetes, the burden of critical limb ischemia is likely to increase in the coming years. Effective revascularization is the cornerstone of treatment; however, it is often hindered by the high rates of restenosis and repeat interventions following conventional balloon angioplasty.”

He added, “As the most promising catheter-based technology for preventing postoperative restenosis in lesions below the knee, the novel MagicTouch PTA sirolimus-coated balloon has emerged. Early data on the efficacy of MagicTouch PTA from small-scale studies are highly encouraging, but these findings require confirmation or refutation. I amFUTURE BTK“Great expectations are placed on this randomized controlled trial, which will evaluate whether the MagicTouch PTA sirolimus-coated balloon can help improve below-the-knee artery patency in patients with critical limb ischemia, potentially bringing us closer to achieving the goal of reducing leg amputations.”

The FUTURE BTK trial will enroll 210 patients with critical limb ischemia classified as Rutherford category 4 to 6. These subjects will be randomized in a 2:1 ratio to receiveMagicTouch PTATreatment, or standard balloon angioplasty. The primary endpoint will be the 6-month primary patency rate, with the peak systolic velocity ratio (PSVR) across both ends of the dissection not exceeding 2.4.

The FUTURE BTK trial was designed to adhere to a rigorous blinded protocol to minimize bias. Patients, care providers, investigators, and outcome assessors, including vascular technologists performing Doppler ultrasound assessments, remained unaware of treatment assignments. Patients will be followed for up to two years.

Website:www.conceptmedical.com