This study is a prospective, single arm, unblinded, and open-label study. The study isdesigned to evaluate the use of the Gentuity Neurovascular Imaging System in patientsundergoing elective neurointerventional diagnostic procedures.
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.
Device: HF-OCT Imaging System with Vis-M Micro-Imaging Catheter
Subjects undergo HF-OCT imaging of the desired intravascular segement
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
Clínica La Sagrada Familia
Buenos Aires, Argentina
Investigator: Pedro Lylyk, MD
Contact: +54 11 4787-2220
info@lylyk.com.ar
Sharon Timberlake, MSHS
(617) 957-1434
stimberlake@gentuity.com
Arjun Bhat, MD, MBA
(978) 202-4108
abhat@gentuity.com
Pedro Lylyk, MD, Principal Investigator
Clínica La Sagrada Familia