Vis-Rx Post-Market Evaluation (Vis-Rx PME)

March 19, 2025 updated by: Gentuity, LLC

Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter

Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.

Study Type

Observational

Enrollment (Actual)

257

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in the cardiac catheterization lab who are candidates for transluminal interventional procedures

Description

Inclusion Criteria:

  • 18 years of age or older
  • Willing and able to provide written informed consent to participate
  • Transluminal interventional procedure for their coronary arteries

General Exclusion Criteria:

  • Bacteremia or sepsis
  • Major coagulation system abnormalities
  • Severe hemodynamic instability or shock
  • Acute renal failure
  • Disqualified for Coronary Artery Bypass Graft (CABG) surgery
  • Disqualified for PCI procedure
  • Currently enrolled in another study to evaluate an investigational device or medication

Lesion-Specific Exclusion Criteria:

  • Total occlusion
  • Coronary artery spasm
  • Large thrombus (visible under angiography)
  • Any target vessel which has undergone a bypass procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HF-OCT imaging
Enrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging
Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance
Time Frame: Immediately after the procedure
Operator evaluation of performance via Likert scale
Immediately after the procedure
Technical performance
Time Frame: Up to 3 months following the procedure
Objective measurement of image clarity of the HF-OCT images by an independent core lab
Up to 3 months following the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete pullbacks
Time Frame: Up to 3 months following the procedure
Percentage of HF-OCT images with maximum clear image length
Up to 3 months following the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gentuity, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Actual)

January 25, 2023

Study Completion (Actual)

January 25, 2023

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

August 31, 2020

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

Other Study ID Numbers

  • 003175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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