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MUSC first in clinical trial to study new stent for CAD
Staff Reports | News Center | November 12, 2013
|The illustration, left, shows the new stent in place covering the area of blockage and a filter above that was used to protect the brain.|
|Photo illustration provided by W.L. Gore & Associates|
There’s a reason MUSC was the first to enroll a patient in a national, multicenter clinical trial to test a new generation of stents to treat carotid artery disease.
Claudio Schonholz, M.D., and his team successfully treated the first patient enrolled in the Gore Carotid Stent Clinical Study for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy (called Scaffold).
“We have many reasons to be proud of this study. We have a close collaboration between vascular surgery, interventional radiology and interventional cardiology,” he said of a team of physicians who meet weekly to collaborate on cases. “A couple of things helped to put us in the front of the line. We were ready before other institutions to enroll the first patient. We got it because we did things right.”
This is important to Schonholz, who has been influential in advancing and improving treatment in cardiovascular interventional radiology since 1989, from helping in the development of an umbrella device that is used during stent implantation to protect the brain from dislodged plaque, to the use of a flow-reversal procedure during stenting that also protects the brain.
According to Schonholz, this investigational study will include up to 50 sites in the nation and will enroll more than 300 patients.“This is something important to me because it’s a less invasive way of treating this problem. We believe that patients are as safe with this technique as they are with the more open operation, and it’s less invasive.”
The more invasive procedure, carotid endarterectomy, involves an incision in the neck so the clogged artery can be opened, the plaque removed and the vessel sutured back together. The less invasive method is to place a stent in that artery to keep the vessel open, but this method also carries risks.
“At the same time we’re doing the procedure to prevent the stroke, the patient is at risk of having a stroke while we are doing it. A piece of the plaque can become lose and go to the brain and cause a stroke.”
Technology continues to advance in an effort to prevent this complication, such as the umbrella that is placed above the blockage during surgery that serves to catch any lose plaque particles. Stents also continue to advance. The model to be used in this study combines the best features of an open-cell stent, one that conforms well to the contours of arterial walls, and a closed stent that prevents plaque from protruding from the stent and dislodging into the bloodstream, he said.
“We learned that what we need is something in between these two.
The new stent is flexible with a net that screens 500 microns that prevents plaque from protruding. This is the most advanced, sophisticated stent designed for the carotid application.”
This is significant as the protruding plaque can break off and cause a stroke, he said.
“The first procedure using the Gore carotid stent was successful and the patient is doing well, having left the hospital the next day. Studies like this will further our understanding of optimal patient outcomes in carotid artery stenosis,” Schonholz said of the patient treated Aug. 6.
“The new Gore device is designed to be flexible, offer plaque retention and stabilization benefits, and along with bound heparin may provide advantages for improved patient outcomes.”
This multicenter, single-arm (only one group of subjects) study will compare this stent to a performance goal developed from carotid endarterectomy outcomes. Co-principal investigators for the national study are Peter Schneider, M.D., Kaiser Permanente Medical Center, Honolulu and William Gray, M.D., Columbia University Medical Center. Schonholz is the principal investigator for MUSC, and also serves as a member of the scientific advisory board at W.L. Gore & Associates, Inc., the entity that manufactures the stent and for whom the study will be conducted.
Patients who are eligible for the study are those who have carotid artery disease and are at high risk for having the more invasive conventional surgery due to other health conditions.
Schonholz believes the interdisciplinary team approach used at MUSC ultimately better serves the patients. “We try to put the patient in the top of our list – what is best for each individual patient,” he said.
Studies such as this and advancements in technology lead to more and better treatment options. “This is what really motivates me when you can be part of something that really brings about a change and results. It’s really motivating.”
For more information about the study, contact Schonholz at firstname.lastname@example.org.