Physio-Anatomy Clinical Data Collection Study

Status Recruiting

Clinical Trial Summary

This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.

Clinical Trial Description

These devices and drugs are commonly used for patient evaluation during PCI procedures performed by Interventional Cardiologists. The three device technologies used in a single catheterization laboratory visit for assessment of the coronary arteries include: - A coronary angiography imaging system to X-ray the coronary arteries for the evaluation of vessel narrowing or blocking. - Pressure guidewire from one or more manufacturers for the measurement of coronary physiology parameters. - Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and sizing of the stenosed coronary arteries. ;

Study Design

Related Conditions & MeSH terms

Coronary Stenosis

Clinical Trial Details

NCT number	NCT05312164
Study type	Observational
Source	Gentuity, LLC
Contact	Arjun Bhat, MD, MBA
Phone	978-202-4108
Email	abhat@gentuity.com
Status	Recruiting
Phase
Start date	March 14, 2022
Completion date	December 31, 2024

View Details

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