Intracranial Arterial AneurysmNCT07117526
Nuvascular Harbor Occlusion Device Pilot Study
A study testing Aneurysm occlusion with an intrasaccular 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?
- Aneurysm occlusion with an intrasaccular device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Oct 2025to 31 Mar 2027
- 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 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
- Diameter 2.5 mm to 12.0 mm
- IA is appropriate for treatment with the HARBOR Occlusion Device per device Instructions for Use
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- Patient has an IA that is appropriate for treatment with HARBOR Occlusion Device without the 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 must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
- Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
Who cannot join
- Patient has a ruptured IA, defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 180 days.
- 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.
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- 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.
- Patient has any circulatory, neurovascular, cardiovascular, or neurologic conditions that have resulted in unstable neurological symptoms.
- Patient has mRS ≥ 2 prior to presentation
- Patient has had an SAH from a non-index IA or any other intracranial hemorrhage within 180 days.
- 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 has a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
- Patient is pregnant.
- 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.
About this study
Official title: The NUVASCULAR HARBOR Occlusion Device Pilot 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, single-center, single arm clinical trial to assess the safety and effectiveness of the HARBOR Occlusion Device for the treatment of unruptured intracranial aneurysms.
- Conditions
- Intracranial Arterial Aneurysm
- Being tested
- Aneurysm occlusion with an intrasaccular device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aneurysm occlusion with an intrasaccular deviceDevice
Intervention with HARBOR Occlusion Device
| Study group | Role | What they receive |
|---|---|---|
| Experimental: The study population includes adults with intracranial aneurysms | Experimental | Intervention: Aneurysm treatment with the HARBOR Occlusion Device Receives: Device: Aneurysm occlusion with an intrasaccular device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants meeting the primary safety and effectiveness endpoints
The study's primary effectiveness endpoint is the proportion of subjects with complete aneurysm occlusion without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment. A subject will be considered an effectiveness success upon meeting all the above criteria.
The study's primary safety endpoint is the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment. A subject will be considered a safety failure upon meeting any of the above criteria. All safety events will be adjudicated by an independent clinical events committee.
Measured: 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 posted12 Aug 2025
- Study start1 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completion31 Mar 2027 (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
- 10 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
- NCT07117526
- Sponsor's protocol ID
- BG-2025-03
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2025
- Last updated
- 17 Mar 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NUVASCULAR HARBOR Occlusion Device Pilot Study
- ClinicalTrials.gov ID
- NCT07117526
- Acronym / sponsor ID
- BG-2025-03
- Conditions
- Intracranial Arterial Aneurysm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nuvascular IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 Aug 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.
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, single-center, single arm clinical trial to assess the safety and effectiveness of the HARBOR Occlusion Device for the treatment of unruptured 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 |
|---|---|---|
| Experimental: The study population includes adults with intracranial aneurysms | Experimental | Device: Aneurysm occlusion with an intrasaccular deviceIntervention: Aneurysm treatment with the HARBOR Occlusion Device |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must be 18-79 years of age at the time of screening.
- Patient must have a single 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 the 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 must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
Key exclusion criteria (17 listed)
- Patient has a ruptured IA, defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 180 days.
- 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.
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 |
|---|---|---|
| Aneurysm occlusion with an intrasaccular deviceIntervention with HARBOR Occlusion Device | Device | Experimental: The study population includes adults with intracranial aneurysms |
Primary outcome
Participants meeting the primary safety and effectiveness endpoints
Time frame: 10-14 months
The study's primary effectiveness endpoint is the proportion of subjects with complete aneurysm occlusion without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment. A subject will be considered an effectiveness success upon meeting all the above criteria. The study's primary safety endpoint is the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment. A subject will be considered a safety failure upon meeting any of the above criteria. All safety events will be adjudicated by an independent clinical events committee.
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 17 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aneurysm occlusion with an intrasaccular 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 9 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 17 Mar 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?
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?
Participants meeting the primary safety and effectiveness endpoints (time frame: 10-14 months). 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 17 Mar 2026.