Physio-Anatomy Clinical Data Collection Study

Gentuity

Status

Enrolling

Conditions

Coronary Stenosis

Treatments

Device: Angiography

Device: FFR Pressure Wire

Device: HF-OCT Imaging

Study type

Observational

Funder types

Industry

Identifiers

NCT05312164

003785

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients >18 years of age.
Patients provide written informed consent.
Clinical presentation consistent with suspected coronary disease.
Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.

Exclusion criteria

Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.
Contraindication for FFR examination or administration of vasodilators.
Bacteremia or sepsis.
Major coagulation system abnormalities.
Severe hemodynamic instability or shock.
Heart Failure NYHA Class IV.
Severe valvular heart disease.
Prior heart transplant.
Acute renal failure based on diagnostic practice of the treating physician at time of screening.
Patient is pregnant.
Patient is currently enrolled in another clinical study that may impact the results of this study.
Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit their