Clinical Trial of Minimally Invasive Stenting System For Carotid Arteries Available At Cedars-Sinai Medical Center
(March 18, 2010) – Patients who suffer from plaque-related narrowing of a carotid artery but are not good candidates for open surgery may be eligible to participate in a clinical trial at Cedars-Sinai Medical Center of a minimally invasive procedure designed to open carotid arteries the way angioplasty and stenting clear arteries of the heart.
The carotid arteries of the neck supply oxygenated blood to the brain. Plaque buildup can lead to stroke by restricting the flow of blood and increasing the risk of clot formation. Early treatment options include lifestyle changes and medications, but a surgical procedure called carotid endarterectomy has been the standard treatment for advanced carotid disease.
An earlier clinical trial of the minimally invasive stenting procedure found it to be comparable to surgery in risks and outcomes. The current trial is a Phase IV multicenter study specifically including patients who are not well enough to undergo open surgery or those thought to be at high risk for surgery.
The procedure is performed in several stages and is usually completed within one to two hours, according to Michael J. Alexander, M.D., director of the Cedars-Sinai Neurovascular Center. Alexander, who also is director of Endovascular Neurosurgery in the Department of Neurosurgery at Cedars-Sinai, is the study’s principal investigator at Cedars-Sinai.
In a specialized neuroangiography suite at Cedars-Sinai that can provide a 3D virtual reality roadmap of the arteries, a thin tube (catheter) is first inserted into an artery of the groin or arm and passed up to the narrowed area in the neck. This catheter serves as a sheath through which smaller catheters are delivered.
When the sheath is in place, a guidewire with an umbrella-like mesh basket at the tip is slipped past the blockage and opened to capture any plaque that may be released during the procedure. A balloon catheter is then passed into the blockage and opened to press the plaque against the artery wall. The nickel titanium (nitinol) mesh stent is then delivered to the area and pressed into the plaque to hold it permanently in place and keep the artery open.
The clinical trial, called SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High Risk for Endarterectomy, is sponsored by Cordis Corp., a Johnson & Johnson company, which makes the PRECISE® Nitinol Stent System and the ANGIOGUARD™ XP Emboli Capture Guidewire. Alexander is a consultant for Codman & Shurtleff, Inc., a company owned by Johnson & Johnson that manufactures other types of diagnostic and therapeutic products.
Patients who are interested in the study may request more information by calling 1-800-CEDARS-1 or visiting “Clinical Trials” at www.cedars-sinai.edu.
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