Hasebe Terumitsu, MD, PhD |Tokai University School of Medicine; Maegawa Shunto, PhD, MBA; Okamoto Yutaka, MEng; Hosaka Makoto, MEng; Edelman R. Elazer, MD, PhD, FACC
Competition Sponsor: Japan Agency for Medical Research and Development
Awardee Year: 2024
Arteriosclerosis obliterans (ASO) causes arterial occlusion in the lower extremities, with risk factors like diabetes, smoking, aging, hypertension, dyslipidemia, and renal failure. In severe cases, the one-year prognosis includes a 30% risk of lower limb amputation and a 25% risk of death. ASO affects over 230 million adults worldwide, and amputation significantly impacts mobility, mental health, and increases the need for social and medical support. Treatment options include surgical bypass and endovascular procedures like catheterization. While above-the-knee treatments have advanced, below-the-knee (BTK) device development faces challenges like smaller vessels, slower blood flow, and high calcification. The standard BTK treatment, balloon catheter dilation, often results in a 70% restenosis rate within three months, requiring repeated interventions. Our team has developed a novel drug-eluting stent to maintain long-term patency in BTK cases. Since 2000, we have focused on the antithrombotic and biocompatible properties of fluorine-doped diamond-like carbon (F-DLC) nanocoating. This has been applied to NiTi stents with an active polymer coating to inhibit reactions to foreign materials, which accelerates vascular healing. This hybrid stent has shown promising preclinical results, maintaining patency for up to six months. Supported by AMED, we have developed both the hybrid stent and its delivery system, with plans for clinical trials aiming for regulatory approval in Japan by 2028. We also intend to expand internationally through joint trials in Japan and the U.S. This stent aims to achieve a restenosis rate of 30% after 12 months, improve patient 5-year survival rates, preserve mobility, and reduce associated disease risks.