Vis-Rx Prime Micro-Imaging Catheter Study

Completed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT06685783

Run by

Gentuity, LLC

People needed

34

Starts

2024-12-11

Expected to finish

2025-05-01

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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