N/A N=34

Vis-Rx Prime Micro-Imaging Catheter Study

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT06685783 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Technical Performance — 56.0 millimeters — p=0.0001

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gentuity, LLC
Primary completion: Apr 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Technical Performance	56.0	0.0001 sig
SECONDARY Clinical Performance Endpoint	4.8; 4.7; 4.8; 4.7	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06685783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.