Neurosurgeons at USC University Hospital recently performed the first procedure in California using a unique, balloon-expandable stent to treat narrowing in the arteries of the brain.
The patient is the first in the state to be in enrolled in the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) clinical trial. The device is aimed at opening blocked arteries (stenosis) in patients who have suffered a stroke and to recover blood flow to the brain.
“Stroke is the third leading cause of death in the U.S.,” said William Mack, assistant professor of neurosurgery at the Keck School of Medicine of USC, who performed the procedure. “For many patients who have suffered a stroke, there is no option available aside from medication to treat the narrowing of the arteries that can lead to a second stroke.”
Patients who have a stroke due to severe narrowing of the vessel have a 24 percent chance of having another stroke in the following year, he noted.
The PHAROS™ Vitesse ™ Neurovascular Stent System is an investigational device in the United States and is the first balloon expandable stent that is specifically designed and tested for intracranial use. Unlike other stents, which require surgeons to open the clogged artery and then insert the stent into the dilated vessel, the PHAROS Vitesse Stent is mounted onto a balloon catheter, which can be precisely positioned across the stenotic portion of the target vessel.
When in position, the balloon is inflated, which expands the stent to the proper diameter of the vessel anatomy. The balloon is then deflated and withdrawn, leaving the stent firmly implanted at the site of the stenotic lesion. The stent is intended to remain permanently implanted in the vessel. Endovascular techniques that employ stents also are potentially less invasive, as they are inserted through the femoral artery in the leg instead of an open surgical procedure.
“Anytime you go into the brain, there are associated risks,” Mack said. “This technique is unique because everything is done in one pass.”
USC University Hospital is the only California site for the randomized international trial that will compare clinical outcomes between patients treated with the balloon-expandable stent and the current best medical practice of treatment with aspirin or Plavix, a medication that helps prevent blood clots. The trial is designed to include up to 250 patients at 30 sites in the United States, Europe and China. The VISSIT trial is sponsored by the San Jose-based Micrus Endovascular Corp., now part of Codman & Shurtleff Inc. The full treatment for patients will include a low cholesterol diet, hypertension management and, if necessary, a smoking cessation program in addition to the blood-thinning drugs.
“The purpose of the VISSIT trial is to investigate what is the best treatment for narrowing arteries due to stroke,” said Donald Larsen, chief medical officer for the USC hospitals and medical director of The Doctors of USC, and lead investigator on the trial. “The balloon expandable stent is technically easier to deploy. We wanted to be involved in the study in order to offer a cutting-edge treatment to enrolled patients.”
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