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New treatment option for Intracranial Aneurysm
Official title Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
ClinicalTrials.gov ID: NCT07214220
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Parent artery has a diameter ≥ 1.3 mm and ≤ 6.0 mm as measured by angiography.
You likely can't join if
- people with a minimum platelet count of \< 100,000/μL.
- people 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%...
- Subject presents with other medical or surgical co-morbidities limiting his/her life expectancy to less than one year
See the full eligibility 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.
- people with a minimum platelet count of \< 100,000/μL.
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Park Ridge, Illinois, United States
- Boston, Massachusetts, United States
- Buffalo, New York, United States
- Buenos Aires, Argentina
- Toronto, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Tampa, Florida, United States; Park Ridge, Illinois, United States; Boston, Massachusetts, United States; Buffalo, New York, United States; Buenos Aires, Argentina and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.