Trial Outcomes & Findings for Vis-Rx Prime Micro-Imaging Catheter Study (NCT NCT06685783)

Results Overview

Clear Image Length of the acquired HF-OCT image during each pullback during a percutaneous coronary intervention procedure

Recruitment status

COMPLETED

Target enrollment

34 participants

Primary outcome timeframe

During percutaneous interventional procedure, up to 2 hours

Results posted on

2026-04-17

Participant Flow

Prospective, Single Group, Unblinded, Multicenter

A total of 90 subjects consented of which 56 were screen failures as a result of not meeting inclusion/exclusion criteria. Of the remaining 34 enrolled, 32 subjects completed the HF-OCT (High Frequency Optical Coherence Tomography) imaging. The remaining two subjects met all inclusion/exclusion and lesion specific criteria, however could not be imaged due to catheter malfunctions prior to HF-OCT Imaging. These two subjects were categorized as "Enrolled-not completed".

Participant milestones

Participant milestones
Measure	HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation Primary Endpoint (Technical Performance): Clear Image Length Evaluation Secondary Endpoint (Clinical Performance) : Evaluation of 4 clinical performance categories using the 5 point Likert scale \[Catheter Preparation, Deliverability, Image Quality, Overall Performance\] Safety Endpoint: Incident Rate for imaging procedure related 'adverse events' observed in the complete study
Overall Study STARTED	34
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation Primary Endpoint (Technical Performance): Clear Image Length Evaluation Secondary Endpoint (Clinical Performance) : Evaluation of 4 clinical performance categories using the 5 point Likert scale \[Catheter Preparation, Deliverability, Image Quality, Overall Performance\] Safety Endpoint: Incident Rate for imaging procedure related 'adverse events' observed in the complete study
Overall Study Device and procedure Malfunction	2

Baseline Characteristics

The male and female count adds up to the overall count.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation n=32 Participants Primary Endpoint (Technical Performance): Clear Image Length Evaluation Secondary Endpoint (Clinical Performance) : Evaluation of 4 clinical performance categories using the 5 point Likert scale \[Catheter Preparation, Deliverability, Image Quality, Overall Performance\] Safety Endpoint: Incident Rate for imaging procedure related 'adverse events' observed in the complete study
Sex: Female, Male Female	12 Participants n=32 Participants • The male and female count adds up to the overall count.
Sex: Female, Male Male	20 Participants n=32 Participants • The male and female count adds up to the overall count.
Region of Enrollment United States	32 Participants n=32 Participants • This number of participants is for the participants recruited in Advocate Hospital in Illinois, Christ Hospital in Ohio and St.Francis Hospital in New York respectively.
Diabetes demographic Diabetes demographic	24 Participants n=32 Participants • This identifies the number of participants of the overall number that had diabetes.
Diabetes demographic Hypertension demographic	27 Participants n=32 Participants • This identifies the number of participants of the overall number that had diabetes.
Age, Continuous	66.5 Years STANDARD_DEVIATION 10.6 • n=32 Participants

PRIMARY outcome

Timeframe: During percutaneous interventional procedure, up to 2 hours

Population: An average of approximately 2.0 pullbacks per participant resulted in images gathered from 65 pullbacks in 32 participants.

Clear Image Length of the acquired HF-OCT image during each pullback during a percutaneous coronary intervention procedure

Outcome measures

Outcome measures
Measure	HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation n=65 Pullbacks Primary Endpoint: Clear Image Length Evaluation The study was statistically powered to this primary endpoint.
Technical Performance	56.0 millimeters Interval 50.3 to 59.9

SECONDARY outcome

Timeframe: During percutaneous interventional procedure, up to 2 hours.

Population: Each participant can have from 0 to 5 pullback to get the HF-OCT image from each pullback. An average of 2 pullbacks per participant yielded a total of 65 pullbacks for 32 participants. The acceptance criteria was that the mean Likert score for each of the 4 measures \[Catheter preparation, Catheter deliverability, Image Quality, Overall performance\] is greater than 3 for all pullbacks.

Clinical performance of the Gentuity HF-OCT Imaging System with the Vis-Rx Prime Micro-Imaging Catheter in a real-world setting as determined by the clinical operator using a Likert Grading Scale (1-5 scale; 1=unacceptable, 5= excellent) for each of the 4 measures \[Catheter preparation, Catheter deliverability, Image Quality, Overall performance\].

Outcome measures

Outcome measures
Measure	HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation n=65 Pullbacks Primary Endpoint: Clear Image Length Evaluation The study was statistically powered to this primary endpoint.
Clinical Performance Endpoint Mean Image Quality	4.8 score on a scale Standard Deviation 0.4
Clinical Performance Endpoint Mean overall performance	4.7 score on a scale Standard Deviation 0.6
Clinical Performance Endpoint Mean Catheter Preparation	4.8 score on a scale Standard Deviation 0.6
Clinical Performance Endpoint Mean Catheter Deliverability	4.7 score on a scale Standard Deviation 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: During percutaneous interventional procedure, up to 2 hours.

Population: Each participant can have 0 to 5 pullbacks to get the HF-OCT image. An average of 2 pullbacks per participant resulted in a total of 65 pullbacks.

Incident Rate based on # of Adverse Events that are potentially related to either the device or the procedure for all 65 pullbacks on 32 participants.

Outcome measures

Outcome measures
Measure	HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation n=65 Pullbacks Primary Endpoint: Clear Image Length Evaluation The study was statistically powered to this primary endpoint.
Safety Endpoint: Incidence of Adverse Events	0 participants

Adverse Events

HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HF-OCT Vis-RX Prime Imaging Catheter Safety and Performance Evaluation n=32 participants at risk Primary Endpoint (Technical Performance): Clear Image Length Evaluation Secondary Endpoint (Clinical Performance) : Evaluation of 4 clinical performance categories using the 5 point Likert scale \[Catheter Preparation, Deliverability, Image Quality, Overall Performance\] Safety Endpoint: Incident Rate for imaging procedure related 'adverse events' observed in the complete study
Blood and lymphatic system disorders Aphasia (post procedure)	3.1% 1/32 • Number of events 1 • Adverse event data were collected during the procedure and up to 1 day following the procedure. The investigator \[Surgeon\] performing the Percutaneous Coronary Intervention \[ PCI\] monitored the participant for any adverse events and documented it on the case report form if applicable.

Additional Information

Dr. Rajesh Kasbekar , Vice-President, Regulatory, Clinical and Quality

Gentuity, LLC

Phone: 7744151484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place