Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter

March 25, 2025 updated by: Gentuity, LLC
This study is a prospective, single arm, unblinded, and open-label study. The study is designed to evaluate the use of the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing elective, neurointerventional procedures, or patient undergoing follow-up diagnostic procedures who meet all inclusion criteria and none of the exclusion criteria will be considered for enrollment. The study investigates the use of the Gentuity Neurovascular Imaging System as a diagnostic tool for intravascular imaging in the cerebrovasculature. The study evaluates the incidence and severity of device-related adverse events, clinical usability performance and technical performance of imaging quality.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1428ARJ
        • Recruiting
        • Clinica La Sagrada Familia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who are electively scheduled for either a follow-up cerebral angiogram or a diagnostic angiogram and may be candidates for a neuroendovascular procedure
  • Patients that present with a Modified Rankin Score (mRS) ≤3
  • Patients 18 years of age or older
  • Patients willing and able to provide written informed consent to participate in evaluation

Exclusion Criteria:

  • Patients with serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk
  • Pregnant
  • Patient has a known hypersensitivity to contrast media
  • Patients undergoing an urgent or emergent neurointerventional procedure
  • Patients that present with a Modified Rankin Score (mRS) ≥4
  • Patients that present with an unresolved spontaneous subarachnoid hemorrhage and/or intracranial hemorrhage
  • Participation in another clinical trial of an investigational drug or device
  • Patient has existing Flow Re-Direction Endoluminal Device (FRED®) System

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurovascular Imaging
Use of the Gentuity HF-OCT Imaging System with Vis-M Micro-Imaging Catheter ("Gentuity Neurovascular Imaging System") as a diagnostic tool for intravascular imaging in the cerebrovasculature.
Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter
Subjects undergo HF-OCT imaging of the desired intravascular segement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Safety
Time Frame: 7 days
Incidence and severity of device-related adverse events.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance
Time Frame: 1 day
Operator evaluation of performance via Likert scale.
1 day
Technical performance
Time Frame: 1 day
Clear image length (CIL) of the vessel
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gentuity, LLC

Investigators

  • Principal Investigator: Pedro Lylyk, MD, Clinica La Sagrada Familia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 003818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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