Vis-Rx Prime Micro-Imaging Catheter Study

Last updated: April 28, 2025
Sponsor: Gentuity, LLC
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Thrombosis

Heart Disease

Treatment

N/A

Clinical Study ID

NCT06685783
MISC-074
  • Ages > 18
  • All Genders

Study Summary

To study the performance of the Gentuity® HF-OCT Imaging System and Vis-Rx Prime® Micro-Imaging Catheter when used to obtain images of coronary arteries in patients who are undergoing cardiac catheterization and are candidates for interventional procedures. The study will evaluate ease of catheter use by physicians using the catheters, image quality and overall performance. The patient's involvement in the study ends when the cardiac catheterization/interventional procedure is completed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 years of age or older

  • Patients willing and able to provide written informed consent to participate inevaluation

  • Patients who are candidates for transluminal interventional procedures for theircoronary arteries (also known as PCI)

Exclusion

Exclusion Criteria:

  • Bacteremia or sepsis

  • Major coagulation system abnormalities

  • Severe hemodynamic instability or shock

  • Acute renal failure

  • Disqualified for Coronary Artery Bypass Graft surgery

  • Disqualified for Percutaneous Coronary Intervention

  • Patients currently enrolled in another study to evaluate an investigational deviceor medication

  • Any target vessel which has undergone a bypass procedure

The lesion-specific exclusion criteria assessed from angiography are:

  • Total occlusion

  • Coronary artery spasm

  • Large thrombus (as visible under angiography)

Study Design

Total Participants: 70
Study Start date:
December 11, 2024
Estimated Completion Date:
July 31, 2026

Study Description

This is a single arm, unblinded, multi-center, clinical evaluation that will be performed at 3 to 5 investigational sites in the United States with subjects who undergo HF-OCT imaging as part of their cardiac catheterization procedure. This study will evaluate a range of device operators (interventional cardiologists) as well as patients and vessels consistent with the product labeling. The operator evaluation will be determined post use of the device using a Likert Grading Scale. Clear Image Length of the acquired HF-OCT image will be measured by an independent core lab. Safety will be monitored through the interventional procedure and Adverse Events that are potentially related to either the device or the procedure will be recorded, evaluated and analyzed.

Connect with a study center

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • St. Francis Hospital and Heart Center

    Roslyn, New York 11576
    United States

    Site Not Available

  • Lindner Research Center at The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

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