Gentuity, LLC
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.
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 c…
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 sep…
Subjects undergo HF-OCT imaging of stenosed coronary arteries
Subjects undergo FFR physiology assessment of stenosed coronary arteries
Subjects undergo angiography imaging of stenosed coronary arteries
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