Home › NCT05312164
Physio-Anatomy Clinical Data Collection Study
RecruitingObservational study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- HF-OCT Imaging (device)
- FFR Pressure Wire (device)
- Angiography (device)
Sponsor: Gentuity, LLC · Participants: 150 · Started: Mar 14, 2022
Contact the study team
- Arjun Bhat, MD, MBA · Phone: 978-202-4108
Official record on ClinicalTrials.gov — NCT05312164
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.