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NEWS
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April 20, 2004 -- No. 226 |
Clinical trial at UNC investigates new treatment
for thoracic aortic aneurysms, related problems
By TOM HUGHES
UNC School of Medicine
CHAPEL HILL -- A clinical trial under way at the University of North Carolina at Chapel Hill is studying the safety and effectiveness of an investigational device in treating thoracic aortic aneurysms and other thoracic aortic pathologies.
In the United States, about 21,000 people annually are diagnosed with thoracic aortic aneurysms. Most patients are older and require many months to recover from traditional open surgery to fix their problems.
"This new therapy will allow these individuals to recover fully within one week and provides a major advancement in the treatment of this difficult problem," said Dr. Mark A. Farber, an assistant professor in the School of Medicine’s division of vascular surgery and UNC’s principal investigator for the trial. Dr. William A. Marston, an associate professor, also is taking part.
The device, called a Talent thoracic stent graft, is essentially a fabric-covered mesh tube that can be placed inside the thoracic aorta, the upper portion of the largest artery leading out of the heart. The stent is delivered by placing it inside a small plastic tube, called a catheter, and threading it up from the femoral artery in the leg to the thoracic aorta. It is manufactured by Medtronic Inc., which is sponsoring the trial.
The primary focus of the study, called the VALOR trial, will be on using the Talent stent to treat patients with thoracic aortic aneurysms, which involve expansion or "pouching" of the aorta wall. Once the stent is in place, it expands to fit within the diameter of the aorta, relieving pressure on the aneurysm and essentially eliminating the chance of a rupture.
Such aneurysms are most commonly caused by hardening of the arteries, but they also can be caused by high blood pressure, congenital disorders and traumatic injuries. This focus of the study is open to patients who are considered candidates for open surgical repair and who have low-to-moderate risk of major complications.
A second focus of the study will include patients with aortic dissection, a condition in which bleeding occurs into and along the wall of the aorta. The actor John Ritter died from this condition. This part of the study examines the Talent stent as a possible new path for blood flow and restoration of blood flow to vital organs, Farber said.
The third focus of the study will include high-risk patients who are not candidates for open surgery and patients with thoracic aortic aneurysms or dissections caused by traumatic injuries that partially sever the aorta, such as those received during a motor vehicle crash. Such cases are life-threatening and require immediate medical intervention.
Stenting offers potential advantages over the two most common treatments for these problems, which are open surgical repair or conservative medical management (sometimes called "watchful waiting"), Farber said. Open surgery can lead to death in elderly patients and can be associated with severe complications, such as the loss of leg function. Conservative medical management usually doesn’t solve the problem and can lead to more deaths and complications among elderly patients, he added.
In contrast, the stenting procedure is less risky than open surgery and more active than watchful waiting, Farber said. Only one small incision is required for entry of the catheter, and, therefore, patients recover from the procedure more quickly and with less pain than from open surgery.
About 100 patients are enrolled in the VALOR trial at 15 active sites. Medtronic ultimately hopes to enroll up to 500 patients at 35 sites.
UNC has 23 patients enrolled and has been the top enrolling center for several months. The other top active sites for patient enrollment include the University of Pennsylvania, where the study’s principal investigator is based; Union Memorial Hospital in Baltimore; the University of Virginia; and Massachusetts General Hospital in Boston.
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Photo note: To download images of the Talent stent, click on:
Note: Contact Farber at (919) 966-3391 or farberm@med.unc.edu.
School of Medicine contact: Stephanie Crayton, (919) 966-2860 or scrayton@unch.unc.edu
