May 12, 2010 – The U.S. Food and Drug Administration (FDA) cleared the way for a clinical trial to evaluate the safety and effectiveness of the Misago self-expanding stent for use in the superficial femoral artery (SFA).
The stent was given received an investigational device exemption (IDE) so the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) could proceed. The trial will simultaneously enroll patients in the United States and Japan. Referred to as Medical Device Collaborative Consultation and Review of Premarketing Applications under the larger FDA "Harmonization by Doing" (HBD) initiative, Terumo's trial was selected as one of two projects to pilot this approach. The process is intended to shorten the gap between product approvals in these two significant world healthcare markets.
HBD 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 the United States toward international regulatory harmonization.
"I believe this approach to shorten the time for new product approvals between the U.S. and Japan is critical and exciting," said Takao Ohki, M.D., 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 United States, OSPREY is a single-arm, multicenter, nonrandomized 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 U.S. study include stent patency rate at one year, as confirmed by duplex ultrasound or angiography. The trial will also look at 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 United States 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 U.S. enrollments are expected in June 2010. The U.S. principal investigator is J. Fritz Angle, M.D., associate professor of radiology, University of Virginia.
"Peripheral vascular disease management continues to be a major clinical problem," said Angle. "We need better tools to improve revascularization of femoral-popliteal vessels. I applaud Terumo's efforts to advance this field."
The Misago self-expanding stent consists of a nitinol stent premounted 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.
For more information: www.terumomedical.com