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

Recruiting now · Not applicable

Conditions studied: Anatomy

In brief

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.

Key facts

Study ID: NCT06078878
Run by: Gentuity, LLC
People needed: 30
Starts: 2023-02-13
Expected to finish: 2026-12-01
Last updated by the study team: 2025-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Clínica La Sagrada Familia — Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

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