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 range

18 Years

Sex

ALL

See this in plain English?

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Coronary Artery Disease trials