Evaluation of a new imaging system for neurointerventional procedures
Official title: Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
Run by Gentuity, LLC · NCT06078878 · Data updated 2026-11-12
This study is testing a new imaging system to see if it can improve the quality of pictures taken during brain blood vessel procedures for patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Gentuity, LLC Industry-sponsored |
| Locations | 1 site (Buenos Aires) |
| Status | Recruiting |
| Started | February 13, 2023 |
| Main results expected | September 2026 |
| Study ends | December 2026 |
| Registry record updated | March 30, 2025 |
| Trial ID | NCT06078878 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 18 and older scheduled for elective cerebral angiograms with a Modified Rankin Score of 3 or less.
✕Probably not a fit
Patients with serious concurrent medical conditions, those undergoing urgent procedures, or those with a Modified Rankin Score of 4 or higher may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures. It is a prospective, single-arm, unblinded, and open-label study that focuses on assessing the device's performance in intravascular imaging of the cerebrovasculature. The study will monitor the incidence and severity of device-related adverse events, as well as the clinical usability and technical performance of the imaging quality.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of neurointerventional procedures through improved imaging techniques.
How similar studies have gone: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel evaluation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Clínica La Sagrada Familia
Buenos Aires, Argentina Recruiting
Study contacts
- Principal investigator: Pedro Lylyk, MD — Clínica La Sagrada Familia
- Study coordinator: Sharon Timberlake, MSHS
- Email: stimberlake@gentuity.com
- Phone: (617) 957-1434
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.