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

Gentuity

Status: Enrolling

Conditions: Anatomy

Treatments: Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT06078878

003818

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Neurovascular Imaging

Experimental group

Description:

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.

Treatment:

Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter