NCT06685783

Vis-Rx Prime Micro-Imaging Catheter Study

Vis-Rx Prime Micro-Imaging Catheter Clinical Evaluation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: Gentuity, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2024-12-11
• Primary completion: 2025-04-30
• Completion: 2025-05-01
• First posted: 2024-11-12
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

3 sites across 1 country: United States