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

Not Applicable

Recruiting

• Conditions: Anatomy
• Interventions: Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter

• Registration Number: NCT06078878
• Lead Sponsor: Gentuity, LLC

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.

Study Timeline

• Study Start: 2023-02-13
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Neurovascular Imaging	HF-OCT Imaging System with Vis-M Micro-Imaging Catheter	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.

Primary Outcome Measures

Name	Time	Method
Device Safety	7 days	Incidence and severity of device-related adverse events.

Secondary Outcome Measures

Name	Time	Method
Technical performance	1 day	Clear image length (CIL) of the vessel
Clinical performance	1 day	Operator evaluation of performance via Likert scale.

Trial Locations

Locations (1)

Clínica La Sagrada Familia; 🇦🇷 Buenos Aires, Argentina