Intracranial AneurysmINSYTENCT07214220
Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
A study testing Endovascular Intracranial aneurysm treatment and nOCT imaging in people with Intracranial Aneurysm, run by Spryte Medical at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Endovascular Intracranial aneurysm treatment and nOCT imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 25 Feb 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States6 sites
Tufts Medical Center, Inc.
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University at Buffalo Neurosurgery (UBNS)
Buffalo, New York, 14203
Baptist Health Research Institute
Jacksonville, Florida, 32207
Advocate Aurora Research Institute
Park Ridge, Illinois, 60068
Tampa General Hospital
Tampa, Florida, 33606
Argentina1 site
ENERI - Clinica La Sagrada Familia Av del Libertador
Buenos Aires
About this study
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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Endovascular Intracranial aneurysm treatment, nOCT imaging
- Keywords
- Intracranial aneurysm treatment, OCT
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Intracranial aneurysm treatmentProcedure or surgery
Endovascular Intracranial aneurysm treatment using devices such as coils, flow diverters, etc. The treatment will include devices that are all FDA approved.
nOCT imagingDevice
During the aneurysm treatment and during the subsequent follow-up, nOCT imaging will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Single arm: Use of nOCT during treatment and follow-up | Experimental | Use of nOCT during intracranial aneurysm treatment and subsequent follow-up Receives: Procedure: Endovascular Intracranial aneurysm treatment; Device: nOCT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse Events
All peri-procedural adverse events (AE) from the index procedure.
Measured: peri-procedural
Effectiveness
Image quality, defined as clear image length (CIL) for images obtained during the index procedure.
Measured: peri-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start25 Feb 2026
- Primary completion17 Jul 2026
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spryte Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214220
- Sponsor's protocol ID
- CIP-001
- Acronym
- INSYTE
- Status last verified
- Jul 2026
- First submitted
- 1 Oct 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: IPD sharing plans are under evaluation pending sponsor policy and regulatory guidance
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
- ClinicalTrials.gov ID
- NCT07214220
- Acronym / sponsor ID
- INSYTE / CIP-001
- Conditions
- Intracranial Aneurysm
- Keywords
- Intracranial aneurysm treatment, OCT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Spryte MedicalIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm: Use of nOCT during treatment and follow-up | Experimental | Procedure: Endovascular Intracranial aneurysm treatment, Device: nOCT imagingUse of nOCT during intracranial aneurysm treatment and subsequent follow-up |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Intracranial aneurysm treatmentEndovascular Intracranial aneurysm treatment using devices such as coils, flow diverters, etc. The treatment will include devices that are all FDA approved. | Procedure or surgery | Single arm: Use of nOCT during treatment and follow-up |
| nOCT imagingDuring the aneurysm treatment and during the subsequent follow-up, nOCT imaging will be performed. | Device | Single arm: Use of nOCT during treatment and follow-up |
Primary outcome
Safety - Adverse Events
Time frame: peri-procedural
All peri-procedural adverse events (AE) from the index procedure.
Effectiveness
Time frame: peri-procedural
Image quality, defined as clear image length (CIL) for images obtained during the index procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided. IPD sharing plans are under evaluation pending sponsor policy and regulatory guidance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Intracranial aneurysm treatment and nOCT imaging in people with Intracranial Aneurysm, run by Spryte Medical at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Argentina, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Adverse Events (time frame: peri-procedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.