Status:
RECRUITING
Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
Lead Sponsor:
Gentuity, LLC
Conditions:
Anatomy
Eligibility:
All Genders
18+ years
Phase:
NA
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 neuroin...
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 considere...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06078878
Start Date
February 13 2023
End Date
December 1 2026
Last Update
March 30 2025
Active Locations (1)
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1
Clínica La Sagrada Familia
Buenos Aires, Argentina, C1428ARJ