Advocate Lutheran General Hospital is the first site in the Midwest and Illinois to join the NECC clinical trial, which offers an innovative investigational treatment for people with a more difficult-to-treat brain aneurysm called a wide-necked, bifurcated saccular, intracranial aneurysm.
An aneurysm is a bulging section of a weakened blood vessel wall, sometimes depicted as an overstretched balloon, that increases the risk for blood vessel rupture. If an aneurysm in the brain ruptures, it causes injury and death to the surrounding brain tissue, which may lead to permanent disability or loss of life. But large, nonruptured brain aneurysms may also cause severe symptoms, such as vision loss, double vision or headaches.
“Implanted medical devices that divert blood away from an aneurysm and through the parent artery are being used increasingly for aneurysm repair,” said Joshua Billingsley, MD, neurosurgeon and the study’s principal investigator for Advocate Aurora Research Institute. “However, in certain cases, wide-necked aneurysms positioned at an artery bifurcation can be more complex to treat due to their size and position where the artery divides. The NECC clinical trial is evaluating a new investigational device, the Contour Neurovascular System™, which was designed to reinforce the vessel wall and divert blood away from the aneurysm while still maintaining good blood flow within the parent artery.”
The Contour system is a mesh device made of braided metal that is delivered to the aneurysm’s location in the brain through a tiny tube, or microcatheter. The microcatheter is inserted into a blood vessel in the groin or upper leg and threaded through the body’s chain of vessels. The mesh device is then implanted inside the aneurysm, and the microcatheter is removed.
“Because of the Contour system design, potential benefits include improved closure of the aneurysm, no blockage of blood flow in the healthy part of the vessel, and no requirement for the patient to remain on long-term anticlotting medications,” said neurosurgeon Demetrius Lopes, MD, director of cerebrovascular surgery and surgical director of the Comprehensive Stroke Program at Advocate Health Care, part of Advocate Aurora Health. Dr. Lopes serves as a co-principal investigator of the U.S. NECC clinical trial.
Researchers plan to enroll 220 people with wide-necked, bifurcated saccular, intracranial aneurysms into the NECC study. Research participants are closely monitored for a period of five years, with follow-up visits scheduled at one, six, 12, 24, 36, 48 and 60 months after the treatment procedure.
“This is an important clinical trial we’re proud to offer as part of our commitment to advance and transform care for our patients and communities through neuroscience research,” said Katie Wozniak, director of neuroscience clinical trials research at the Research Institute. “Although this device is investigational in the U.S., it has already been approved for use in both the United Kingdom and European Union. We are pleased to be one of the first hospitals in the U.S. to offer this trial.”
The clinical trial, “U.S. IDE study of the Contour Neurovascular System™ for intracranial aneurysm repair (NECC),” is sponsored by Cerus Endovascular, Ltd., the manufacturer of the device.
To learn more about Advocate Aurora’s research, visit aah.org/research.
