Physio-Anatomy Clinical Data Collection Study

Last updated: March 19, 2025
Sponsor: Gentuity, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Treatment

HF-OCT Imaging

FFR Pressure Wire

Angiography

Clinical Study ID

NCT05312164
003785
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 thecardiac catheter lab with the intent to perform a physiological assessment for denovo lesions with stenosis, if clinically indicated.

Exclusion

Exclusion Criteria:

  • Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cathlab 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 timeof screening.

  • Patient is pregnant.

  • Patient is currently enrolled in another clinical study that may impact the resultsof this study.

  • Patient has other co-morbid condition(s) that, in the opinion of the Investigator,could limit their

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: HF-OCT Imaging
Phase:
Study Start date:
March 14, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Veteran's Administration Palo Alto

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Atlanta VA Medical Center

    Decatur, Georgia 30033
    United States

    Active - Recruiting

  • Baptist Health

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota 55417
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

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