RecruitingNot ApplicableNCT06078878

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

Sponsor

Gentuity, LLC

Enrollment

30 participants

Start Date

Feb 13, 2023

Study Type

INTERVENTIONAL

Conditions

Anatomy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria8

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