Terumo Medical, a U.S. subsidiary of the Tokyo-based Terumo, has officially begun its OSPREY trial, which will evaluate the safety and efficacy of the Misgao peripheral self-expanding stent system for use in the superficial femoral artery (SFA), at the first enrolling facility, Bradenton Cardiology Center in Bradenton, Fla.
The OSPREY (Occlusive/Stenotic Peripheral artery REvascularization StudY) will seek to enroll patients in Japan and the U.S., according to Terumo. In the U.S., OSPREY is a single-arm, multicenter, non-randomized prospective trial for the treatment of atherosclerotic stenoses and occlusions of the SFA. In Japan, there are two arms of the study, 50 patients receiving the Misgao stent system and 50 patients receiving percutaneous transluminal angioplasty.
The primary endpoints of the U.S. study are:
- Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography; and
- Freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularization, amputation of the treated limb or death.
The study will include up to 350 patients, a maximum of 250 patients in up to 30 centers in the U.S. and 100 patients in Japan. Terumo received FDA approval for the trial in May, and it has already begun enrolling patients in Japan, where the company received regulatory approval to begin the trial last year. The stent is currently for sale in Europe.
Srinivas Iyengar, MD, will serve as Bradenton’s principal investigator for the trial.