This marks the company’s first clinical trial in the USA for a premarket approval (PMA) device. A unique feature of the clinical trial is that it will simultaneously enroll patients in USA and Japan.
Terumo has recently announced it has received an investigational device exemption (IDE) conditional approval from the USA Food and Drug Administration (FDA) for its OSPREY(Occlusive/Stenotic Peripheral Artery Revascularization Study) in the USA, which will evaluate the safety and effectiveness of the Misago self-expanding stent system for use in the superficial femoral artery (SFA). This marks the company’s first clinical trial in the USA for a premarket approval (PMA) device. A unique feature of the clinical trial is that it will simultaneously enroll patients in USA and Japan. Referred to as “Medical device collaborative consultation and review of premarketing applications” under the larger “Harmonization by Doing” initiative, Terumo’s 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.
The initiative is an international effort to develop global clinical trials and address regulatory barriers that may be impediments to timely device approvals. This process is a cooperative effort to move both Japan and USA toward international regulatory harmonization by seeking regulatory convergence between FDA and Japan’s regulatory bodies MHLW-PMDA. The learning obtained in the “proof of concept” trials will assist both regulatory bodies in streamlining the clinical trial process for faster approvals in both countries, as well as promote the idea of global trials for purposes of collecting better data. In this pilot harmonisation study, the products will be submitted for review and approval at the same time.
“I believe this approach to shorten the time for new product approvals between USA and Japan is critical and exciting,” said Takao Ohki, chairman and professor, Department of Surgery, Jikei University School of Medicine, Division of Vascular Surgery, and the global principal investigator of the OSPREY trial. “This innovative movement could dramatically solve the current device lag issue between our countries.”
In the USA, OSPREY is a single-arm, multicentre, 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 and 50 patients receiving percutaneous transluminal angioplasty (PTA).
The primary endpoints of the OSPREY in the USA are:
- Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography.
- 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 USA and 100 patients in Japan. There have already been six patients enrolled in Japan, which received regulatory approval to begin the trial last year. The first enrollments in the USA are expected in June 2010. The principal investigator in USA is J Fritz Angle, associate professor of Radiology, University of Virginia.
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. The stent is currently available for sale in Europe.