NCT06685783Completed
Vis-Rx Prime Micro-Imaging Catheter Study
Vis-Rx Prime Micro-Imaging Catheter Clinical Evaluation Study
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 34 (actual)
- First submitted
- 11 Nov 2024
- Start date
- 11 Dec 2024
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Gentuity, LLC
- Diseases
- Coronary artery disease
- NCT number
- NCT06685783
What you commit to
- Study type: Observational
- Participants enrolled: 34
- From 11 Dec 2024 to the primary completion date, 30 Apr 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Disqualified for Coronary Artery Bypass Graft surgery
- Patients currently enrolled in another study to evaluate an investigational device or medication
Other illness
- Acute renal failure
Other
- Bacteremia or sepsis
- Major coagulation system abnormalities
- Severe hemodynamic instability or shock
- Disqualified for Percutaneous Coronary Intervention
- 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)
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lindner Research Center at the Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Advocate Lutheran General Hospital Coordinator of this site? Confirm its status | Park Ridge | United States | Unknown status |
| St. Francis Hospital and Heart Center Coordinator of this site? Confirm its status | Roslyn | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.