CompletedNot Applicable

Vis-Rx Prime Micro-Imaging Catheter Study

United States34 participantsStarted 2024-12-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Technical Performance

Timeframe: During percutaneous interventional procedure, up to 2 hours

Trial details

NCT IDNCT06685783

SponsorGentuity, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-30

Results submitted2026-01-27