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

Last updated: March 25, 2025
Sponsor: Gentuity, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

HF-OCT Imaging System with Vis-M Micro-Imaging Catheter

Clinical Study ID

NCT06078878
003818
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who are electively scheduled for either a follow-up cerebral angiogram or adiagnostic 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 inevaluation

Exclusion

Exclusion Criteria:

  • Patients with serious concurrent medical conditions including bacteremia or sepsis,acute renal failure at the time of the procedure, and major coagulation systemabnormalities that in the opinion of the investigator could significantly increaserisk

  • 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/orintracranial hemorrhage

  • Participation in another clinical trial of an investigational drug or device

  • Patient has existing Flow Re-Direction Endoluminal Device (FRED®) System

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter
Phase:
Study Start date:
February 13, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Clínica La Sagrada Familia

    Buenos Aires, C1428ARJ
    Argentina

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.