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Vis-Rx Prime Micro-Imaging Catheter Study
Sponsor: Gentuity, LLC
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.
Official title: Vis-Rx Prime Micro-Imaging Catheter Clinical Evaluation Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
70
Start Date
2024-12-11
Completion Date
2026-07
Last Updated
2025-04-29
Healthy Volunteers
No
Conditions
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