Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • HF-OCT Imaging System with Vis-M Micro-Imaging Catheter

    Device

    Subjects undergo HF-OCT imaging of the desired intravascular segement

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Neurovascular ImagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Device Safety

Incidence and severity of device-related adverse events.

Time frame
7 days

Secondary outcomes

1

Clinical performance

Operator evaluation of performance via Likert scale.

Time frame
1 day
2

Technical performance

Clear image length (CIL) of the vessel

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gentuity, LLC

Lead sponsor

Source ClinicalTrials.gov
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