Status:
NOT_YET_RECRUITING
Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
Lead Sponsor:
Spryte Medical
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 tak...
Eligibility Criteria
Inclusion
- 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
- 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 ipsilateral carotid or vertebral artery stenosis greater than 50%
- Subject underwent stenting, angioplasty, or endarterectomy procedures of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment.
- Subject has 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
- Subject has severe intracranial vasospasm not responsive to medical therapy
- Subject has chronic kidney disease stage ≥ 4 and is not undergoing dialysis
- The subject is pregnant or breastfeeding at the time of admission or plans to become pregnant during their participation in the trial
- Subject is currently participating in another clinical research trial involving an investigational device or drug
- Subject is under judicial protection or legal guardianship
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT07214220
Start Date
February 1 2026
End Date
February 28 2029
Last Update
October 17 2025
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