Vis-Rx Prime Micro-Imaging Catheter Study

Vis-Rx Prime Micro-Imaging Catheter Clinical Evaluation Study

To study the performance of the Gentuity® HF-OCT (High Frequency Optical Coherence Tomography) 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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
  • New York
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital and Heart Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Research Center at The Christ Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in the cardiac catheterization lab who are candidates for PCI

Description

Inclusion Criteria:

• Patients 18 years of age or older
• Patients willing and able to provide written informed consent to participate in evaluation
• Patients who are candidates for transluminal interventional procedures for their coronary arteries (also known as PCI)

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 device or 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Performance	Clear Image Length of the acquired HF-OCT image during each pullback during a percutaneous coronary intervention procedure	During percutaneous interventional procedure, up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Performance Endpoint	Clinical performance of the Gentuity HF-OCT Imaging System with the Vis-Rx Prime Micro-Imaging Catheter in a real-world setting as determined by the clinical operator using a Likert Grading Scale (1-5 scale; 1=unacceptable, 5= excellent) for each of the 4 measures [Catheter preparation, Catheter deliverability, Image Quality, Overall performance].	During percutaneous interventional procedure, up to 2 hours.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint: Incidence of Adverse Events	Incident Rate based on # of Adverse Events that are potentially related to either the device or the procedure for all 65 pullbacks on 32 participants.	During percutaneous interventional procedure, up to 2 hours.

Collaborators and Investigators

• Sponsor: Gentuity, LLC

Publications and helpful links

General Publications

• Swanson, E. A. & Fujimoto, J. G. The ecosystem that powered the translation of OCT from fundamental research to clinical and commercial impact [Invited]. Biomedical optics express 8, 1638-1664, doi:10.1364/BOE.8.001638 (2017).
• van der Sijde, J. N. et al. Safety of optical coherence tomography in daily practice: a comparison with intravascular ultrasound. European heart journal cardiovascular Imaging 18, 467-474, doi:10.1093/ehjci/jew037 (2017).
• D'Ascenzo, F. et al. Impact of design of coronary stents and length of dual antiplatelet therapies on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 102 735 patients. European heart journal 38, 3160-3172, doi:10.1093/eurheartj/ehx437 (2017).
• Dilmanian, H. et al. The average stent length is longer and the average stent diameter is shorter in patients with drug-eluting stents versus bare-metal stents during percutaneous coronary intervention. Am J Ther 14, 277-279, doi:10.1097/MJT.0b013e3180653377 (2007).
• Al-Sunduqchi, M. S. Determining the Appropriate Sample Size for Inferences Based on the Wilcoxon Statistics. (University of Wyoming. Department of Statistics, 1990).
• Yoon, J. H. et al. Feasibility and safety of the second-generation, frequency domain optical coherence tomography (FD-OCT): a multicenter study. The Journal of invasive cardiology 24, 206-209 (2012).

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: MISC-074

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No