Individuals between 30 and 80 years of age, who have had a transient ischemic attack (TIA) or non-severe stroke within the past 30 days, and who cannot be treated surgically, may be eligible to participate in a Phase III clinical trial of a minimally invasive stenting procedure at the Cedars-Sinai Neurovascular Center. The study will focus specifically on patients who have had an intracranial artery narrowed by at least 70 percent and who are experiencing recurrent strokes or TIAs despite being on anti-clotting medication.
Cedars-Sinai is one of approximately 60 institutions participating in the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study of the WingspanTM intracranial stent with GatewayTM balloon. The five-year study will compare the safety and effectiveness of either intensive medical therapy plus stenting or intensive medical therapy alone to prevent another stroke or death in patients with narrowed brain blood vessels.
Neurosurgeon Michael J. Alexander, M.D., director of the Cedars-Sinai Neurovascular Center and principal investigator of the study at Cedars-Sinai, is on the National Institutes of Health steering committee for the study. "Although angioplasty and stenting procedures have become common in treating blocked heart arteries, stenting in the brain has been more challenging because brain arteries are less muscular and, therefore, more delicate than those of the heart," he said.
The WingspanTM stent has been designed to be more flexible to accommodate these fragile arteries of the brain. It is delivered through a catheter inserted in the groin and threaded through blood vessels to the brain. The stent was previously approved by the Food and Drug Administration as a humanitarian use device - meaning it could only be used on a limited basis in special circumstances. The nationwide Phase III clinical trial was launched late last year, and if the study finds the experimental device to be safe and effective, it could be approved for use without these restrictions.
Patients who qualify to participate in the clinical trial will be eligible for study-related medical care paid through the study. Each participant will be involved in the study for a minimum of one year and a maximum of three years. More than 700 patients are expected to participate nationwide.
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