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

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: Anatomy
• Intervention / Treatment: Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter

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

• Study Contact: Name: Sharon Timberlake, MSHS; Phone Number: (617) 957-1434; Email: stimberlake@gentuity.com
• Study Contact Backup: Name: Arjun Bhat, MD, MBA; Phone Number: (978) 202-4108; Email: abhat@gentuity.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1428ARJ
    • Recruiting
    • Clínica La Sagrada Familia
    • Contact: Pedro Lylyk, MD; Phone Number: +54 11 4787-2220; Email: info@lylyk.com.ar

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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
Safety	Incidence and severity of device-related adverse events.	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gentuity, LLC
• Investigators: Principal Investigator: Pedro Lylyk, MD, Clínica La Sagrada Familia

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

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): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

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