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Observational Study of Coronary Artery Imaging

This study is collecting information from patients who have narrowed coronary arteries (coronary stenosis) and are already scheduled for heart procedures. It uses three common tools: angiography (X-rays of your arteries), FFR pressure wire (to measure blood flow), and the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter (to get detailed images and measurements of your arteries). The goal is to gather data from these tools during your procedure to better understand coronary stenosis. You might be able to join if you are over 18, have suspected coronary disease, and are a candidate for a procedure called PCI (percutaneous coronary intervention) where these assessments are planned.

Study design
This is an observational study, meaning it collects information during your standard medical care, not testing a new treatment. It plans to include about 150 participants.
What's involved
You would undergo HF-OCT imaging, FFR pressure wire assessment, and angiography imaging of your stenosed coronary arteries during a single catheterization laboratory visit.
Compensation
Not stated in the trial record.
Follow-up
Data collection, including images and pressure wire data, will be measured at 2 years.

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NCT05312164

Physio-Anatomy Clinical Data Collection Study

Recruiting
Not specifiedAges 18+Observational
Gentuity, LLC
~150 participants
Updated 2025-03-20 on ClinicalTrials.gov
What's tested:HF-OCT ImagingFFR Pressure WireAngiography

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Collection of angiography images, HF-OCT images, and FFR pressure wire data
Measured over 2 years

Conditions

Coronary Stenosis

Explore related trials

Coronary Artery Stenosis

Where it's being run

6 sites across 6 states
California1
Florida1
Georgia1
Massachusetts1
Minnesota1
Ohio1

Who to contact

Arjun Bhat, MD, MBA
[email protected]
978-202-4108
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Collection of angiography images, HF-OCT images, and FFR pressure wire data2 years

    There are no efficacy or safety outcomes in this study. This study is a simple data collection study to help the sponsor develop next-generation HF-OCT software. Pressure wire data will be paired with HF-OCT images and angiography images for analysis to determine if the HF-OCT imaging technology can predict FFR physiology information from the OCT pullback.