Researchers at the UC Davis National Center for Interventional Biophotonic Technologies have completed the first human trial of a device designed to detect and treat atherosclerosis, a condition that narrows blood vessels due to plaque buildup.
The flexible, catheter-based tool moves through artery walls, gathering real-time data on plaque accumulation. Laura Marcu, the center’s founding director, stated that this technology could improve understanding of cardiovascular disease progression and enable personalized treatment.
Dual-imaging technology for plaque analysis
The device uses fluorescence lifetime imaging and polarization-sensitive optical coherence tomography to simultaneously evaluate plaque microstructure and biochemistry in coronary arteries.
Julien Bec, who leads engineering and regulatory efforts in the Marcu Lab, developed both the catheter and the imaging console. He explained that fluorescence imaging identifies the artery wall’s natural biochemical signals, while optical tomography maps its microstructure.
Bec noted that it is uncommon for an academic group to conduct such a human study with a lab-developed catheter system, as this task is typically handled by large companies.
From animal models to human trials
After successful tests in animal models and human artery samples, the researchers received FDA approval to test the device in 10 patients. They completed imaging for the final participant in August.
Cardiovascular disease is the leading cause of death in the United States. Plaque buildup in arteries can lead to heart attacks, strokes, and other cardiac issues.
Traditional cardiac catheterization examines blood vessel structure and microstructure but does not provide information on biochemical composition, which is essential for understanding plaque instability and rupture.
The new device combines imaging technologies to analyze both microstructure and biochemistry in a single pullback, a process for retracting the catheter while capturing live images.
Real-time imaging of coronary arteries
Marcu described the catheter as a small, compatible device that enters the human heart, rotates, pulls back, and quickly captures images detailing the composition and microstructure of blood vessels.
As it moves through coronary vessels into the beating heart, the catheter captures color images of the artery wall’s structure and composition. In two seconds, it images an 80-millimeter length of a coronary artery during retraction.
The catheter can identify plaque buildup before it develops into stenosis, the abnormal narrowing of blood vessels that restricts normal blood flow.
Jeffrey Southard, a UC Davis interventional cardiologist, emphasized the risk of sudden plaque rupture, which can cause blood clots and heart attacks. The catheter provides vital information on plaque biochemistry, indicating inflammation and potential rupture risk. Future research will determine the best treatment methods for different plaque types.
Southard led the patient testing, with postdoctoral researcher Xiangnan Zhou operating the system in the cath lab.
Enhancing treatment strategies
Stenosis treatment often involves stent placement. The location and method of stent deployment, along with drug selection, significantly affect long-term treatment success.
The researchers plan to expand the study to include more patients. Marcu expressed hope that the technology will be adopted in cath labs to evaluate plaque composition and pathobiology, guiding treatment and stent deployment.