Dual-Imaging Catheter Completes Initial Human Evaluation of Coronary Plaque

Atherosclerosis involves plaque buildup in arterial walls that can narrow blood vessels and increase the risk of heart attack, stroke, and other serious cardiovascular conditions. In coronary arteries, catheter-based imaging can reveal vessel structure but does not show plaque biochemistry, which is linked to instability and rupture. To provide this additional information, researchers at UC Davis have completed a first-in-human test of a catheter-based device designed to assess plaque biochemistry.

Developed at the UC Davis National Center for Interventional Biophotonic Technologies (NCIBT), the device combines fluorescence lifetime imaging with polarization-sensitive optical coherence tomography in a flexible catheter platform. Together, these technologies capture real-time information about the microstructure and biochemical composition of plaque within coronary arteries.

The system acquires both types of information during a single pullback, as the catheter rotates and is withdrawn through the artery while recording live images inside the beating heart. It can image an 80-millimeter segment in two seconds, producing color images that show arterial wall structure and composition.

Following testing in animal models and human coronary artery samples, the team received U.S. Food and Drug Administration (FDA) approval this year to evaluate the system as an investigational device in 10 patients. Imaging of the final patient was completed in August, marking completion of the initial clinical evaluation.

By revealing plaque buildup before it causes stenosis, or abnormal vessel narrowing that can restrict blood flow, the device may provide information to guide stent placement and drug selection. These decisions can influence long-term treatment success, and the team now plans to expand the study to include more patients.

“Plaque can rupture suddenly and create blood clots that could lead to a heart attack. The catheter will reliably provide information about the biochemistry of the plaque that may indicate inflammation and possible risk of rupture or erosion. Through more research we will learn the best ways to treat this and other types of plaque,” said UC Davis interventional cardiologist Jeffrey Southard. 

“Testing this device marks a major step toward advancing heart health. Our technology could help clinicians better understand atherosclerotic cardiovascular disease progression and personalize treatment,” said Laura Marcu, founding director of NCIBT.

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