Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Ima
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.
| Condition(s) | Anatomy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Gentuity, LLC |
| Locations | Buenos Aires, Argentina |
| Start date | 2023-02-13 |
| NCT ID | NCT06078878 |
| Official listing | https://clinicaltrials.gov/study/NCT06078878 |