Intracranial Arterial AneurysmNCT07900464
The NUVASCULAR HARBOR Occlusion Device EU Study
A study testing HARBOR Occlusion Device in people with Intracranial Arterial Aneurysm, run by Nuvascular Inc at 1 site in Bulgaria.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the HARBOR Occlusion Device for treating brain aneurysms. The HARBOR Device is investigational (experimental), meaning the Regulatory Authorities have not approved it for commercial use. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Intracranial Arterial Aneurysm
- What is being tested?
- HARBOR Occlusion Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBulgaria
- Study dates
- 26 Oct 2026to 18 Dec 2028
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be 18-79 years of age at the time of screening.
- Patient must have a single ruptured (defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of Subarachnoid Hemorrhage (SAH) attributed to the index aneurysm within the last 60 days) or unruptured IA requiring treatment. If the subject has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure.
- The index IA to be treated must have the following characteristics:
- Saccular in shape/morphology
- Equatorial width 2 mm to 12 mm
- Absolute neck size ≥ 4mm and < 7mm AND Dome-to-Neck (DN) ratio ≥1 OR Dome-to-Neck (DN) ratio 1 to 2
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- IA is appropriate for treatment with the HARBOR Occlusion Device per device Instructions for Use
- Patient has an IA that is appropriate for treatment with HARBOR Occlusion Device without anticipated use of additional implanted devices
- Patient must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
- Patient or legally authorized representative must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
- FOR PATIENTS WITH UNRUPTURED ANEURYSM
- Patient meets the criteria outlined in the "Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association" as published by the AHA/ASA (2015 or current version at the time of screening).
- FOR PATIENTS WITH RUPTURED ANEURYSM
- Patient is neurologically stable with no seizure at the onset of the SAH, not requiring External Ventricular Drain (EVD) placement prior to inclusion
- Patient meets the criteria outlined in the "Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association" as published by the AHA/ASA (2023 or current version at the time of screening).
- Patient must be neurologically stable with Hunt and Hess scale (HHS) of II or less at the time of treatment
- Patient must be mRS < 2 prior to presentation or aneurysm rupture
Who cannot join
- Patient has an IA with characteristics unsuitable for endovascular treatment.
- Microcatheter could not reach patient's index aneurysm to allow necessary access to treat with study device.
- Patient has vessel characteristics, tortuosity or morphology which could preclude safe access and support during treatment with study device;
- Patient has vascular disease or other vascular anomaly so as to preclude the necessary access to the aneurysm for use of the study device.
- Patient has clinical, angiographic or CT evidence of vasospasm, vasculitis, or intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
- Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 60 days.
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- Patient has any circulatory, neurovascular, cardiovascular, or neurologic conditions that have resulted in unstable neurological symptoms.
- Patient has mRS > 3 prior to presentation
- Patient has physical, neurologic or psychiatric conditions which preclude his/her ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
- Patient's index IA was previously treated.
- Patient has a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
- Pregnant or breastfeeding women.
- Patient has known hypersensitivity, which cannot be medically treated, to any component of the study implant device (primarily nickel-titanium alloy), procedural materials, or medications commonly used during the procedure.
- Patient is concurrently involved in another investigational study or a post-market study that could affect the safety and effectiveness of IA treatment with the study device or with the study's follow-up schedule.
- Patient has an acute life-threatening illness other than the neurological disease to be treated in this trial.
- Patient has a life expectancy of less than 2 years due to other illness or condition (in addition to an intracranial aneurysm).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bulgaria1 site
University Hospital St. Ivan Rilski
Sofia
Stanimir Sirakov, MD, PhD, DmSc, 9496362753, mattfitz@nuvascular.com
About this study
The purpose of this study is to evaluate the safety and effectiveness of the HARBOR Occlusion Device for treating brain aneurysms. The HARBOR Device is investigational (experimental), meaning the Regulatory Authorities have not approved it for commercial use. The data collected in this research study will be used to analyze whether the HARBOR Device is safe and effective in treating brain aneurysms.
Read the detailed description
Nuvascular is sponsoring a prospective, multi-center, single arm clinical trial to assess the safety and effectiveness of the HARBOR Occlusion Device for the treatment of intracranial aneurysms.
- Conditions
- Intracranial Arterial Aneurysm
- Being tested
- HARBOR Occlusion Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARBOR Occlusion DeviceDevice
The HARBOR Occlusion Device is a self-expanding braided nitinol implant delivered through a microcatheter for endovascular treatment of intracranial aneurysms.
| Study group | Role | What they receive |
|---|---|---|
| HARBOR Occlusion Device | Experimental | Participants with eligible intracranial aneurysms will receive endovascular treatment with the HARBOR Occlusion Device. The device is delivered through a microcatheter and implanted in the target aneurysm. Participants will undergo protocol-specified clinical, neurological, and imaging assessments through the 1-year follow-up visit. Receives: Device: HARBOR Occlusion Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, or Significant Parent Artery Stenosis.
Proportion of participants with complete aneurysm occlusion and no retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis (>50%) at 1 year after treatment. Participants must meet all criteria to be counted as an effectiveness success.
Measured: 1 year after treatment (10-14 months)
Proportion of Participants with Nonaccidental Death Cause or Major Stroke
Proportion of participants with death from any nonaccidental cause or major stroke within 30 days after treatment, or major ipsilateral stroke or death due to a neurological cause from day 31 through 1 year after treatment. Major stroke is defined as an ischemic or hemorrhagic stroke resulting in an increase of at least 4 points on the NIH Stroke Scale.
Measured: From treatment through 1 year after treatment (10-14 months).
Secondary outcomes (1)
Angiographic Aneurysm Recurrence
Proportion of participants with angiographic aneurysm recurrence, defined as aneurysm growth or recanalization at 1 year after treatment.
Measured: 1 year after treatment (10-14 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion18 Dec 2027 (estimated)
- Study completion18 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Arterial 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuvascular Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900464
- Sponsor's protocol ID
- 2025-04
- Other IDs
- CIV-26-04-057507
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NUVASCULAR HARBOR Occlusion Device EU Study
- ClinicalTrials.gov ID
- NCT07900464
- Acronym / sponsor ID
- 2025-04
- Conditions
- Intracranial Arterial Aneurysm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nuvascular IncIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 18 Dec 2027 (estimated)
- Study completion
- 18 Dec 2028 (estimated)
- First posted
- 28 Oct 2026 (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.
The purpose of this study is to evaluate the safety and effectiveness of the HARBOR Occlusion Device for treating brain aneurysms. The HARBOR Device is investigational (experimental), meaning the Regulatory Authorities have not approved it for commercial use. The data collected in this research study will be used to analyze whether the HARBOR Device is safe and effective in treating brain aneurysms.
Detailed description
Nuvascular is sponsoring a prospective, multi-center, single arm clinical trial to assess the safety and effectiveness of the HARBOR Occlusion Device for the treatment of intracranial aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HARBOR Occlusion Device | Experimental | Device: HARBOR Occlusion DeviceParticipants with eligible intracranial aneurysms will receive endovascular treatment with the HARBOR Occlusion Device. The device is delivered through a microcatheter and implanted in the target aneurysm. Participants will undergo protocol-specified clinical, neurological, and imaging assessments through the 1-year follow-up visit. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient must be 18-79 years of age at the time of screening.
- Patient must have a single ruptured (defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of Subarachnoid Hemorrhage (SAH) attributed to the index aneurysm within the last 60 days) or unruptured IA requiring treatment. If the subject has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure.
- The index IA to be treated must have the following characteristics:
- Patient has an IA that is appropriate for treatment with HARBOR Occlusion Device without anticipated use of additional implanted devices
- Patient must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
Key exclusion criteria (16 listed)
- Patient has an IA with characteristics unsuitable for endovascular treatment.
- Microcatheter could not reach patient's index aneurysm to allow necessary access to treat with study device.
- Patient has vessel characteristics, tortuosity or morphology which could preclude safe access and support during treatment with study device;
- Patient has vascular disease or other vascular anomaly so as to preclude the necessary access to the aneurysm for use of the study device.
- Patient has clinical, angiographic or CT evidence of vasospasm, vasculitis, or intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
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 |
|---|---|---|
| HARBOR Occlusion DeviceThe HARBOR Occlusion Device is a self-expanding braided nitinol implant delivered through a microcatheter for endovascular treatment of intracranial aneurysms. | Device | HARBOR Occlusion Device |
Primary outcome
Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, or Significant Parent Artery Stenosis.
Time frame: 1 year after treatment (10-14 months)
Proportion of participants with complete aneurysm occlusion and no retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis (>50%) at 1 year after treatment. Participants must meet all criteria to be counted as an effectiveness success.
Proportion of Participants with Nonaccidental Death Cause or Major Stroke
Time frame: From treatment through 1 year after treatment (10-14 months).
Proportion of participants with death from any nonaccidental cause or major stroke within 30 days after treatment, or major ipsilateral stroke or death due to a neurological cause from day 31 through 1 year after treatment. Major stroke is defined as an ischemic or hemorrhagic stroke resulting in an increase of at least 4 points on the NIH Stroke Scale.
1 secondary outcome
Angiographic Aneurysm Recurrence
Time frame: 1 year after treatment (10-14 months)
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HARBOR Occlusion Device in people with Intracranial Arterial Aneurysm, run by Nuvascular Inc at 1 site in Bulgaria.
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 17 inclusion and 16 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, or Significant Parent Artery Stenosis. (time frame: 1 year after treatment (10-14 months)). 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 28 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.