Vis-Rx Prime Micro-Imaging Catheter Study

Active, not recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT06685783
• Lead Sponsor: Gentuity, LLC

Brief 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.

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 Timeline

• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-12
• Study Start: 2024-12-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-12-31
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical performance	During percutaneous interventional procedure	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)
Technical Performance	During percutaneous interventional procedure	Clear Image Length of the acquired HF-OCT image

Trial Locations

Locations (3)

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States

St. Francis Hospital and Heart Center; 🇺🇸 Roslyn, New York, United States

Lindner Research Center at The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States