Evaluating a Multisensor Wireless Pressure Microcatheter for Diagnosing Coronary Microvascular Dysfunction in Adults with ANOCAINOCA A Prospective Multicenter Single-Group Study

What this Trial Is About

This research aims to evaluate how well a multi-sensor wireless pressure microcatheter can diagnose Coronary Microvascular Dysfunction CMD in patients who have angina with normal or near-normal coronary arteries ANOCAINOCA. The study compares this microcatheters measurements to those from cardiac magnetic resonance CMR imaging, which assesses myocardial blood flow quantitatively. It is a prospective, multicenter study focused on patients showing less than 50% coronary artery narrowing and specific blood flow reserve values. Participants will undergo assessment using the multi-sensor wireless pressure microcatheter during their diagnostic procedure. The study collects data intraoperatively and up to 7 days afterward to measure coronary flow reserve and other microvascular function indices. The microcatheters results will be compared against CMR quantitative myocardial perfusion imaging, considered the reference standard for this evaluation. During the study, participants will have their coronary microvascular function assessed and monitored through imaging and pressure measurements. Researchers will analyze the accuracy, sensitivity, specificity, and predictive values of the microcatheter compared to CMR. The primary outcome focuses on the devices diagnostic performance within one week of the procedure. This study involves consenting adult patients and includes follow-up assessments during the first week after the procedure.

Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study