Actively Recruiting
Intravascular Neuro OCT Imaging System for Evaluating Intracranial Aneurysm Treatment
Led by Spryte Medical · Updated on 2026-05-15
67
Participants Needed
8
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the nOCT (neuro optical coherence tomography) Imaging System, a new medical device designed to take images from inside blood vessels in the brain. This investigational study focuses on patients undergoing treatment for intracranial aneurysms, either ruptured or unruptured. The goal is to assess the safety and effectiveness of the nOCT system in providing detailed images to help doctors diagnose and monitor aneurysm treatment. This study is sponsored by Spryte Medical and involves an interventional approach without masking or blinding. The study uses the nOCT Imaging System, which includes a small, flexible probe and a console with a computer, screen, and laser light. The probe is inserted through catheters already in the patient's blood vessels during their planned aneurysm treatment. The system delivers low-power laser light to scan the blood vessel walls, producing images that doctors review during treatment and follow-up. Participants receive endovascular treatment with FDA-approved devices such as coils or flow diverters, and the nOCT imaging is performed during both the treatment and subsequent follow-up periods. Participants will undergo imaging assessments using the nOCT system alongside their planned aneurysm treatments. The study tracks safety by monitoring adverse events occurring around the procedure and evaluates the quality of images produced by the device. Researchers will review these outcomes peri-procedurally. Participants are expected to comply with follow-up visits and study requirements, which include clinical evaluations and imaging as part of their aneurysm care. The total study duration extends until February 2029, allowing for ongoing monitoring and data collection.
CONDITIONS
Brief Title
Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Pre-procedure modified Rankin Scale (mRS) score of 3 or less
- Undergoing planned treatment for ruptured or unruptured intracranial aneurysm
- Understands the investigational procedure and consents to participation
- Willing to comply with study follow-up requirements
- Parent artery diameter between 1.3 mm and 6.0 mm as measured by angiography
You will not qualify if you...
- Platelet count less than 100,000/µL
- Ischemic stroke or transient ischemic attack within the past 30 days
- Acutely ruptured aneurysm with Hunt & Hess score 4 or higher
- Infectious, blister-like, fusiform, dissecting, traumatic, or mycotic aneurysm
- Anatomy unsuitable for safe catheter delivery, including stenosis over 70% or excessive tortuosity
- Medical or surgical conditions limiting life expectancy to less than one year
- Unlikely to comply with study protocol or follow-up
- Conditions increasing risk of embolic stroke
- Allergy or contraindication to heparin, iodinated contrast, or dual-antiplatelet medication
- Ipsilateral carotid or vertebral artery stenosis greater than 50%
- Stenting, angioplasty, or endarterectomy within 30 days prior to treatment
- Serious medical conditions such as bacteremia, sepsis, acute renal failure, or major coagulation abnormalities
- Severe intracranial vasospasm not responsive to medical therapy
- Chronic kidney disease stage 4 or higher not on dialysis
- Pregnant or breastfeeding, or planning pregnancy during participation
- Currently in another clinical trial involving an investigational device or drug
- Under judicial protection or legal guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of treatment
Participants undergo endovascular intracranial aneurysm treatment using FDA-approved devices with nOCT imaging performed during the procedure.
1 treatment visit (in-person)
Duration - Up to several months post-treatment
Participants receive nOCT imaging during follow-up visits to evaluate the aneurysm treatment over time.
Multiple follow-up visits with nOCT imaging (in-person)
Trial Site Locations
Total: 8 locations
1
Baptist Health Research Institute
Jacksonville, Florida, United States, 32207
Actively Recruiting
2
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
3
Advocate Aurora Research Institute
Park Ridge, Illinois, United States, 60068
Actively Recruiting
4
Tufts Medical Center, Inc.
Boston, Massachusetts, United States, 02111
Actively Recruiting
5
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
6
University at Buffalo Neurosurgery (UBNS)
Buffalo, New York, United States, 14203
Not Yet Recruiting
7
ENERI - Clinica La Sagrada Familia Av del Libertador
Buenos Aires, Argentina
Not Yet Recruiting
8
St. Michael's Hospital
Toronto, Canada
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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