Actively Recruiting
Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
Led by Gentuity, LLC · Updated on 2025-03-30
30
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients electively scheduled for a follow-up cerebral angiogram or diagnostic angiogram and may be candidates for neuroendovascular procedures
- Patients with a Modified Rankin Score (mRS) of 3 or less
- Patients 18 years of age or older
- Patients willing and able to provide written informed consent
You will not qualify if you...
- Patients with serious medical conditions such as bacteremia, sepsis, acute renal failure at the time of procedure, or major coagulation abnormalities increasing risk
- Pregnant patients
- Known hypersensitivity to contrast media
- Patients undergoing urgent or emergent neurointerventional procedures
- Patients with a Modified Rankin Score (mRS) of 4 or more
- Patients with unresolved spontaneous subarachnoid hemorrhage or intracranial hemorrhage
- Participation in another clinical trial of investigational drug or device
- Patients with an existing Flow Re-Direction Endoluminal Device (FRED4) System
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clínica La Sagrada Familia
Buenos Aires, Argentina, C1428ARJ
Actively Recruiting
Research Team
S
Sharon Timberlake, MSHS
CONTACT
A
Arjun Bhat, MD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
1
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