UC Davis Health has enrolled its first patient in a groundbreaking clinical trial evaluating an advanced carotid stent system designed to reduce stroke risk in patients with carotid artery disease. The C-Guardians II Trial represents a significant advancement in vascular intervention technology, with UC Davis serving as one of only five hospital sites nationwide participating in this major clinical study.
The first patient, Roderick Wood, had been diagnosed with carotid artery disease and elevated Lipoprotein (a) levels, placing him at increased risk for stroke, heart attack, and aortic stenosis. Wood was approached by Dr. Misty D. Humphries, UC Davis Health interim chief of vascular surgery and co-director of the heart and vascular center, to participate in the trial using the innovative CGuard Prime carotid stent system.
Advanced Stent Technology Addresses Critical Safety Gap
The CGuard Prime stent system addresses a fundamental limitation of traditional carotid stents. According to Dr. Humphries, conventional stents carry the risk of plaque slipping through the wire mesh, potentially causing blockages and strokes. The CGuard Prime stent features a special outer covering that helps keep plaque in place, reducing both immediate procedural stroke risk and the likelihood of future plaque accumulation at the treatment site.
"She clearly explained the procedure and potential benefits of participating in the trial, so I decided to do it," Wood recalled. "I am all for new technology and I figured this could further the science for the next person in my position."
Comprehensive Neuroprotection System
The C-Guardians II Trial evaluates the safety and effectiveness of the CGuard Prime carotid stent system (80cm) used in conjunction with the FDA-cleared ENROUTE Transcarotid Neuroprotection System (NPS). This combination provides enhanced brain protection during Transcarotid Artery Revascularization (TCAR), a minimally invasive alternative to traditional surgery for high-risk patients.
The ENROUTE system employs a unique mechanism that temporarily reverses blood flow direction in the carotid artery, capturing loose plaque or debris before it can reach the brain. Rather than using traditional filters placed higher in the artery, the system collects and filters blood through a specialized controller, then safely returns cleaned blood through a leg vein.
During the TCAR procedure, physicians insert a small sheath into the carotid artery and connect it to the ENROUTE system. With reversed blood flow established, the team uses a balloon and the CGuard Prime stent to open the narrowed artery and secure plaque, significantly reducing future stroke risk.
Exceptional Patient Outcomes
Wood's recovery exemplified the minimally invasive nature of the procedure. After one night of hospital observation, he was discharged with remarkable results. "I figured with an incision that size, I would have felt some discomfort, but I had zero pain," Wood reported. "I didn't even need to take a Tylenol."
The successful outcome has given Wood confidence to proceed with the same procedure on his left carotid artery. "After the success of this first procedure, I feel good about getting my left-side done and being able to move forward without the worry of suffering a stroke from any buildup," he shared.
Leading Center for TCAR Excellence
UC Davis Health's participation in this trial builds on its established expertise in carotid intervention. The medical center has performed over 200 TCAR procedures since 2019, representing the highest volume in the Sacramento region. This experience has earned UC Davis Health designation as a TCAR Center of Excellence, recognizing superior care team quality and patient outcomes.
"We are committed to advancing innovation in vascular care," said Dr. Humphries. "Enrolling our first patient in this important study shows just how committed we are to giving physicians reliable tools that help protect patients from stroke — both safely and effectively."
The C-Guardians II Trial represents a critical step forward in carotid artery disease management, potentially offering improved safety and efficacy for patients requiring intervention to prevent stroke. With only five sites conducting this study nationwide, UC Davis Health's participation underscores its role in advancing cardiovascular care through clinical research and innovation.
