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

NCT06078878 | Recruiting FDA Device

• 1 other identifier: 003818
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anatomy

Outcome Measures

Primary Outcomes (1)

• Device Safety

  Incidence and severity of device-related adverse events.

  7 days

Secondary Outcomes (2)

• Clinical performance

  1 day

• Technical performance

  1 day

Study Arms (1)

Neurovascular Imaging

EXPERIMENTAL

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

Interventions

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

Subjects undergo HF-OCT imaging of the desired intravascular segement

Neurovascular Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gentuity, LLC: lead

Study Sites (1)

Clínica La Sagrada Familia

Buenos Aires, C1428ARJ, Argentina

RECRUITING

Study Officials

• Pedro Lylyk, MD

  Clínica La Sagrada Familia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Timberlake, MSHS

CONTACT

(617) 957-1434; stimberlake@gentuity.com

Arjun Bhat, MD, MBA

CONTACT

(978) 202-4108; abhat@gentuity.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 12, 2023
• Study Start: February 13, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)