Anatomy
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEHF-OCT Imaging System with Vis-M Micro-Imaging Catheter
Subjects undergo HF-OCT imaging of the desired intravascular segement
Sponsors
Gentuity, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Safety | 7 days | Incidence and severity of device-related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance | 1 day | Operator evaluation of performance via Likert scale. |
| Technical performance | 1 day | Clear image length (CIL) of the vessel |
Countries
Argentina
Contacts
Primary ContactSharon Timberlake, MSHS
Backup ContactArjun Bhat, MD, MBA
Outcome results
None listed