MUSC became one of the first centers nationwide to implant the MISAGO Self-expanding Stent System, as part of a clinical trial evaluating the system's ability to improve blood flow to the lower extremities for patients suffering from peripheral artery disease (PAD).
The clinical trial, called the Occlusive/Stenotic Peripheral artery REvascularization Study (OSPREY) in the U.S., will evaluate the safety and efficacy of the stent system for use in the superficial femoral artery (SFA), the main blood vessel that supplies blood to the legs and feet.
For patients suffering from PAD, the MISAGO stent system offers a way to improve blood flow to clogged vessels that supply blood to the lower extremities. An estimated eight million Americans suffer from PAD, with the most common symptoms including cramping, pain or tiredness of the leg or hip muscles while walking or climbing stairs. Most cases of PAD can be managed with lifestyle changes and medical therapy; however, left untreated, this condition can lead to gangrene and amputation of the affected limb.
Marcelo Guimaraes, M.D., MUSC assistant professor of vascular & interventional radiology and principal investigator on the study, said MUSC is pleased to be a part of this landmark trial.
"This is a unique and exciting opportunity to be a part of the first international initiative to streamline the regulatory process to facilitate future medical device approvals between countries. I believe this is also important, because it will increase the population awareness of peripheral arterial disease, its symptoms, how to prevent it and how to manage it adequately."
A unique feature of the OSPREY clinical trial is that it will simultaneously enroll patients in the U.S. and Japan. Referred to as "Medical Device Collaborative Consultation and Review of Premarketing Applications" under the larger Harmonization by Doing (HBD) initiative, the trial was selected to pilot this approach of shortening the gap between product approvals in these two significant world healthcare markets. The pilot program is a cooperative effort led by the U.S. Food & Drug Administration, the MHLW-PMDA (Japan's regulatory bodies), Terumo Corporation based in Tokyo, Japan, and Terumo Medical Corporation, a U.S.–based subsidiary of Terumo Corporation.
PAD is highly prevalent among individuals with a history of smoking, diabetes, high blood pressure, high cholesterol and in the elderly population. According to Guimaraes, patients who visit the Vascular & Interventional Radiology (VIR) clinic at MUSC have their complaints thoroughly evaluated, with limb pulses and blood pressures checked for about 20 minutes.
"We offer an inexpensive and quick way to grade the level of disease and to make a decision if further diagnostic studies or immediate treatment are needed. It is a great opportunity to educate our patients and to prevent this terrible and highly prevalent disease," Guimaraes said. "The Peripheral Vascular Disease screening program is offered at no additional cost to all patients who come to the VIR clinic at MUSC. We have a multidisciplinary approach in the evaluation of patients with PVD. MUSC is a medical institution where the best therapy—either by risk factors management, medications, open surgery or minimally invasive procedures—is offered for the treatment of any vascular disease from head to toe."
In the U.S., OSPREY is a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the SFA and will include up to 350 patients involving 30 centers in the U.S.
For more information, visit http://www.muschealth.com/pvd/index.htm.