Physio-Anatomy Clinical Data Collection Study

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.

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