Tests of New Self-Expanding Stent for Use in the Superficial Femoral Artery Will Be the First "Harmonized Clinical Trial" in the US and Japan

Terumo Medical Corporation’s Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) trial is part of a pilot project intended to shorten the gap between product approvals in these two significant world healthcare market.

Terumo Medical Corporation recently announced it had received approval for the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) study, which will “evaluate the safety and effectiveness of the MISAGO™ Self-expanding Stent System for use in the superficial femoral artery (SFA).” According to Terumo, the MISAGO Self-expanding Stent “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.”

OSPREY will simultaneously enroll patients in the US and Japan as part of the "Harmonization by Doing" (HBD) initiative. The FDA website describes the HBD initiative as “a pilot project launched in December 2003 that seeks regulatory convergence between FDA and MHLW-PMDA premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD will utilize parallel development, application submissions and review of actual medical device projects by FDA and MHLW-PMDA in conjunction with the above-named constituencies. The objective is to eliminate redundancies, added costs, and time delays inherent in sequential trials. The intent of HBD is not simply to create guidance and discuss policy but to develop common protocols for investigational clinical studies that would allow safe and effective "breakthrough" cardiovascular technologies to benefit patients worldwide.”

According to the press release, Terumo's 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.”

ClinicalTrials.gov says that OSPREY is a “multi-center, single arm, non-randomized, prospective clinical trial” for the treatment of atherosclerotic stenoses and occlusions of the SFA. Subjects will “undergo a SFA stent procedure using the Misago™ Peripheral Self Expanding stent” once all of the inclusion and none of the exclusion criteria are met.” Stent efficacy and safety will be evaluated “immediately post procedure, and at 30 days, 6, 12, 24, and 36 months post procedure. A subject is considered enrolled into the OSPREY study after he/she signs the informed consent and meets all inclusion/exclusion criteria.”

According to the press release, the Japanese study will feature two arms: 50 patients will receive the MISAGO Stent and 50 patients will receive percutaneous transluminal angioplasty (PTA). The US study will include up to 250 patients in up to 30 centers. Six patients have already been enrolled in Japan, which received regulatory approval to begin the trial last year. The first US patients are expected to enroll in June.

Takao Ohki, MD, Chairman and Professor, Department of Surgery, Jikei University School of Medicine, Division of Vascular Surgery, and the global principal investigator of the OSPREY trial said that he believes that the HBD approach will “shorten the time for new product approvals between the US and Japan” and that this “innovative movement could dramatically solve the current device lag issue between our countries."

US principal investigator J. Fritz Angle, MD, Associate Professor of Radiology, University of Virginia, said that "Peripheral vascular disease management continues to be a major clinical problem,” necessitating the need for “better tools to improve revascularization of femoral-popliteal vessels."

Jim Takeuchi, President and CEO, Terumo Medical Corporation, said that his company is excited and proud to participate in this “precedent-setting international collaborative effort between regulators, industry, clinical researchers, patients, and academia” and that Terumo “looks forward to initiating our first PMA clinical trial in the United States and to bringing innovative new interventional technology to market to improve patients' quality of life."