Physio-Anatomy Clinical Data Collection 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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Stenosis
• Intervention / Treatment: Device: HF-OCT Imaging; Device: FFR Pressure Wire; Device: Angiography

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Arjun Bhat, MD, MBA; Phone Number: 978-202-4108; Email: abhat@gentuity.com

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Veteran's Administration Palo Alto
      • Principal Investigator: William Fearon, MD
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
      • Contact: Thanh Tran; Phone Number: 813-844-8544; Email: tqtran@usf.edu
      • Principal Investigator: Hiram Bezerra, MD
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Recruiting
      • Atlanta VA Medical Center
      • Principal Investigator: Gautam Kumar, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Principal Investigator: Eric A Osborn, MD, PhD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Recruiting
      • Minneapolis VA Medical Center
      • Principal Investigator: Alok Sharma, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital
      • Principal Investigator: Jarrod Frizzell, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who are candidates for PCI who already have a scheduled visit to the cardiac cath lab.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Candidates for PCI; Patients undergoing diagnostic cardiac catheterization/PCI.	Device: HF-OCT Imaging; Subjects undergo HF-OCT imaging of stenosed coronary arteries; Device: FFR Pressure Wire; Subjects undergo FFR physiology assessment of stenosed coronary arteries; Device: Angiography; Subjects undergo angiography imaging of stenosed coronary arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of angiography images, HF-OCT images, and FFR pressure wire data	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.	2 years

Collaborators and Investigators

• Sponsor: Gentuity, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Coronary Stenosis
• Other Study ID Numbers: 003785

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No