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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anatomy

Intervention / Treatment
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* Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurovascular Imaging<br>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<br>* Subjects undergo HF-OCT imaging of the desired intravascular segement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Incidence and severity of device-related adverse events. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance | Operator evaluation of performance via Likert scale. | 1 day | 
| Technical performance | Clear image length (CIL) of the vessel | 1 day |