Terumo announced the first US patient implant in the occlusive/stenotic peripheral artery revascularisation study (OSPREY), which will evaluate the safety and efficacy of its MISAGO peripheral self-expanding stent system for use in the superficial femoral artery (SFA).
A unique feature of the OSPREY clinical trial is that it will simultaneously enrol patients in the US and Japan. Referred to as “Medical device collaborative consultation and review of premarketing applications” under the larger harmonisation by doing HBD initiative. The OSPREY trial was selected as one of two projects to pilot this approach, which is intended to shorten the gap between product approvals in these two significant world healthcare markets.
In the US, OSPREY is a single-arm, multi-centre, non-randomised prospective clinical 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 MISAGO stent system and 50 patients receiving percutaneous transluminal angioplasty.
The primary endpoints of the US 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 revascularisation, amputation of the treated limb or death.
The study will include up to 350 patients, a maximum of 250 patients in up to 30 centres in the US and 100 patients in Japan. Japan received regulatory approval to begin the trial last year and has already started to enrol patients.
The MISAGO peripheral self-expanding stent system consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. The unique design distributes the dynamic superficial femoral artery stress loads throughout the stent’s struts providing not only flexibility, but also durability against bending, compression, and torsion. The MISAGO stent system features the first rapid-exchange delivery catheter for use in the SFA.