Terumo Interventional Systems has completed enrolling patients in its Occlusive/Stenotic Peripheral Artery REvascularization StudY (OSPREY).
The MISAGO stent comprises a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system and has three radiopaque markers located on each end to help ensure accurate placement in the lesion.
The multi-center, non-randomized, 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 as a treatment for atherosclerotic stenoses and occlusions of the superficial femoral artery.
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 larger harmonization by doing (HBD) pilot program led by the US Food and Drug Administration, the MHLW/PMDA, Terumo Corporation, as well as Terumo Medical Corporation, according to the company.
Terumo Interventional Systems and Onset Medical president James Rushworth said the company is appreciative of the tremendous support given by US clinical investigators, which helped to meet the critical enrollment 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.