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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06078878
Other study ID # 003818
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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