iVascular Initiates Trial of Luminor DCB in Japan

April 15, 2021—iVascular announced the commencement of recruitment of the first study in Japan of the company’s Luminor drug-coated balloon (DCB). The SOL-JAPAN trial is the first step for obtaining registration for Luminor DCB in Japan. iVascular is conducting the trial in partnership with Medicos Hirata, a Japanese company.

According to iVascular, the single-arm, prospective, multicenter, nonrandomized open trial will evaluate the safety and effectiveness of Luminor DCB when treating superficial femoral artery and proximal popliteal artery lesions. The trial’s primary endpoint is the primary patency of the target lesion at 12 months after procedure and the secondary endpoints are device success, procedural success, and clinical success, among others.

The study will enroll 120 participants of centers in Japan followed through 5 years with assessments at 30 days, 6 months, and each year out to 5 years.

The first case with the Luminor DCB in the trial was performed at Kokura Memorial Hospital in Kitakyushu, Japan, by Yoshimitsu Soga, MD, Investigator-Coordinator of SOL-JAPAN. The results of this trial will be key to achieving the commercialization of Luminor in Japan, noted the announcement.

Luminor is a paclitaxel-coated balloon with platforms for different guidewire compatibility including 0.014, 0.018, and 0.035 inches. It is specifically designed to treat stenosis in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, either original or artificial, stated iVascular.