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

NCT ID: NCT06078878

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2026-12-31

Brief 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.

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.

Conditions

Anatomy

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Subjects undergo HF-OCT imaging of the desired intravascular segement

Interventions

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

Subjects undergo HF-OCT imaging of the desired intravascular segement

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gentuity, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Lylyk, MD

Role: PRINCIPAL_INVESTIGATOR

Clínica La Sagrada Familia

Locations

Clínica La Sagrada Familia

Buenos Aires, , Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Sharon Timberlake, MSHS

Role: CONTACT

stimberlake@gentuity.com

(617) 957-1434

Arjun Bhat, MD, MBA

Role: CONTACT

abhat@gentuity.com

(978) 202-4108

Facility Contacts

Pedro Lylyk, MD

Role: primary

info@lylyk.com.ar

+54 11 4787-2220

Other Identifiers

003818

Identifier Type: -

Identifier Source: org_study_id