Physio-Anatomy Clinical Data Collection Study
Start Date
3/14/2022
Completion Date
12/31/2025
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.
Detailed 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
HF-OCT Imaging
FFR Pressure Wire
Angiography
Conditions
Locations
Veteran's Administration Palo Alto
Palo Alto, California 94304
United States
Tampa General Hospital
Tampa, Florida 33606
United States
Atlanta VA Medical Center
Decatur, Georgia 30033
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Minneapolis VA Medical Center
Minneapolis, Minnesota 55417
United States
The Christ Hospital
Cincinnati, Ohio 45219
United States