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

Anatomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078878
• Other study ID #: 003818
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: Gentuity, LLC
• Contact: Sharon Timberlake, MSHS
• Phone: (617) 957-1434
• Email: stimberlake[@]gentuity.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomy

Intervention

Device:
• HF-OCT Imaging System with Vis-M Micro-Imaging Catheter
Subjects undergo HF-OCT imaging of the desired intravascular segement

Locations

Country	Name	City	State
Argentina	Clínica La Sagrada Familia	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Gentuity, LLC

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Incidence and severity of device-related adverse events.	7 days
Secondary	Clinical performance	Operator evaluation of performance via Likert scale.	1 day
Secondary	Technical performance	Clear image length (CIL) of the vessel	1 day