Active — Not RecruitingNot Applicable

Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation

United States, Argentina, Canada67 participantsStarted 2026-02-25

Plain-language summary

This is an investigational study for a new medical device called the nOCT (neuro optical coherence tomography) Imaging System, which is manufactured by Spryte Medical, LLC. The nOCT Imaging System takes pictures from inside a blood vessel in your brain. These pictures give your doctor information about the inside of your blood vessel including the disease and any implanted devices. The nOCT Imaging System consists of a probe and a console. The probe is a small, flexible wire-like device designed to navigate through catheters which have already been inserted in your body as part of your planned procedure. Catheters are small, flexible, tubes inserted in your blood vessels which allow your doctor to deliver treatments such as medications, coils, or stents directly to the affected area. The console is a unit that includes a computer, screen and laser light source. The probe is connected to the console. The console provides the probe with low-power light from the laser which is used to scan and create pictures of your blood vessel. The pictures are displayed on the screen of the console for review by your doctor and may be stored for future viewing. The objective of the study is to evaluate the safety and effectiveness of the nOCT Imaging System to provide quality images for diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Subject age ≥ 18 and ≤ 75 years Subject has a pre-procedure mRS ≤ 3 Subject is undergoing a planned treatment for an intracranial aneurysm, unruptured or ruptured Subject understands the investigational procedure, consents to participation, is willing to comply with study follow-up requirements and provides a signed informed consent document Parent artery has a diameter ≥ 1.3 mm and ≤ 6.0 mm as measured by angiography. Exclusion Criteria: Subjects with a minimum platelet count of \< 100,000/μL. Subjects who have suffered an ischemic stroke or transient ischemic attack within the past 30 days. Subject has an acutely ruptured aneurysm with a Hunt \& Hess score ≥ 4 Subject has an infectious, blister-like, fusiform, dissecting, traumatic or mycotic aneurysm confirmed by angiography Subject has challenging anatomy that in the investigator's opinion is not suitable for safe delivery of an 0.021" catheter, including stenosis \> 70% or excessive tortuosity Subject presents with other medical or surgical co-morbidities limiting his/her life expectancy to less than one year Subject is, in the opinion of the investigator, unlikely to comply with the study protocol or follow-up requirements. Subject with any condition which in the opinion of the treating physician would place the subject at an elevated risk of embolic stroke Subject with known allergy or other contraindication to heparin, iodinated contrast, or dual-antiplatelet medication Subject has …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety - Adverse Events

Timeframe: peri-procedural

Effectiveness

Timeframe: peri-procedural

Trial details

NCT IDNCT07214220

SponsorSpryte Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-17

View on ClinicalTrials.gov More Intracranial Aneurysm trials