Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
ConditionAnatomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGentuity, LLC
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- HF-OCT Imaging System with Vis-M Micro-Imaging Catheter
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov