Life Goes On After Stenting Procedure Opens Brain Artery Not Accessible By Surgery - Wingspan Stent Clinical Trial At Cedars-Sinai

Main Category: Neurology / Neuroscience
Also Included In: Cardiovascular / Cardiology;  Medical Devices / Diagnostics;  Stroke
Article Date: 25 Feb 2009 - 4:00 PDT

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Los Angeles resident Kelvin Kelley rarely, if ever, got sick, had managed to avoid doctors for more than 40 years and had never even taken a prescription drug. But last year he began to have occasional episodes of weakness and a feeling that he might pass out. At one point, he did black out for a second while driving and thought he might be having some kind of panic attack.

"It was sort of odd. I couldn't describe what was going on because I had no prior knowledge of it," said Kelley, 59.

On Memorial Day weekend his girlfriend rushed him to Cedars-Sinai Medical Center because he suddenly felt weak and unable to stand. But by the time they arrived at the emergency room, he was able to walk from the car into the hospital, where he continued to have episodes of weakness in his arms and legs.

An MRI and a magnetic resonance angiogram of the brain detected a nearly 90 percent blockage of the basilar artery, which supplies oxygenated blood to a part of the brain and brain stem controlling a variety of functions, including breathing and strength of the arms and legs.

Surgery is rarely considered for this condition because the artery is situated in a remote location at the base of the skull and attempts to access it often result in stroke, according to Michael J. Alexander, M.D., director of the Cedars-Sinai Neurovascular Center and professor of neurosurgery at Cedars-Sinai. Kelley's options came down to long-term medical management - the use of drugs to try to prevent further narrowing of the artery and maintain blood flow - or angioplasty and stent placement to unclog the artery and keep it open.

Although angioplasty and stenting procedures have become common in the treatment of blocked heart arteries, stenting in the brain has been more challenging because the arteries are more tortuous and delicate than those of the heart. Attempts to use heart stents in the brain often resulted in hemorrhaging, but a more flexible stent - the WingspanTM stent is now being studied.

The WingspanTM stent has been 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 - but a major Phase III clinical trial is now underway. If the study finds the experimental device to be safe and effective, it could be approved for use without these restrictions.

On May 21, under the humanitarian use protocol, Alexander threaded a catheter through blood vessels from the groin to the blocked artery in Kelley's brain, performing a balloon angioplasty and inserting a WingspanTM stent. The procedure was accomplished in about an hour and Kelley was discharged the following day.

"This is a minimally invasive procedure performed through a pinhole incision in the groin, but it can have a life-saving impact," Alexander said. "Mr. Kelley's intermittent symptoms were caused by small, transient strokes that were a warning that he was getting ready to have a major stroke. Patients who even survive a stroke in the basilar artery usually end up with paralysis on one or both sides and in most cases are ventilator-dependent for the rest of their lives. He hasn't had any symptoms since the stent was placed, and he is resuming a normal, active life."

The SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study of the WingspanTM intracranial stent with GatewayTM balloon is funded by the National Institutes of Health. Alexander is on the NIH steering committee for the study, and Cedars-Sinai is one of approximately 50 institutions participating. According to the study protocol, the stent may be placed within 30 days of stroke onset. If the patient's insurance does not cover the costs of the angioplasty, stenting and related hospitalization, or if the patient does not have insurance, there is a process in place to make it possible for the patient to participate. The study nurse will assist patients with this process.

http://www.cedars-sinai.edu