Physio-Anatomy Clinical Data Collection Study for Coronary Stenosis Using FDA-Cleared Cardiac Catheterization Technologies

What this Trial Is About

Researchers are collecting data on three FDA-cleared cardiac catheterization devices and drugs used during procedures to evaluate coronary artery blockages. The study focuses on patients with suspected coronary disease who are candidates for percutaneous coronary intervention (PCI). It aims to gather detailed images and physiological measurements to understand the condition of narrowed coronary arteries using standard medical practices. Participants will undergo three types of assessments during a single visit to the catheterization lab: coronary angiography to X-ray the arteries, fractional flow reserve (FFR) pressure wire measurement to assess blood flow physiology, and high-frequency optical coherence tomography (HF-OCT) imaging to visualize and size the stenosed arteries. All procedures use approved devices and drugs as labeled and per routine clinical care. During the study, researchers will collect angiography images, HF-OCT images, and FFR pressure wire data over a two-year period. Participants provide informed consent and undergo evaluations consistent with clinical standards. The study monitors these images and measurements to better understand coronary artery disease and how these technologies perform in clinical practice.

Physio-Anatomy Clinical Data Collection Study