Terumo Interventional Systems has completed enrolment of patients in its occlusive / stenotic peripheral artery revascularization study (OSPREY), designed to assess the company's Misago self-expanding stent system as a treatment for atherosclerotic stenoses and occlusions of the superficial femoral artery.
The Misago stent, which comprises of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system, has three radiopaque markers located on each end to help ensure accurate placement in the lesion.
The multicentre, non-randomised, prospective single-arm study, which has enrolled 200 US patients and 100 Japanese patients, is designed to assess the safety and efficacy of Misago stent system.
The primary endpoints of study include primary stent patency rate at one year, as confirmed by duplex ultrasound, and freedom from major adverse events within 30 days of the procedure.
The study enrolled patients in the US and Japan, as part of the harmonisation by doing (HBD) pilot programme, led by the US Food and Drug Administration, the MHLW / PMDA and Terumo Corporation, as well as the Terumo Medical Corporation, according to the company.
James Rushworth, Terumo Interventional Systems and Onset Medical president, said the company is greatly appreciative of the tremendous support given by US clinical investigators, which helped to meet the critical enrolment goal in the landmark HBD initiative.
"The OSPREY trial and the Misago stent truly speak to our three strategic pillars of introducing innovative technologies that create clinical, economic and quality of life benefits," Rushworth added.
Image: The OSPREY trial will assess the Misago stent system as a treatment for peripheral artery diseases. Image courtesy of: Terumo Medical Corporation.