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Not yet recruitingNCT07900464Updated Nov 2, 2026

The NUVASCULAR HARBOR Occlusion Device EU Study

An interventional study of HARBOR Occlusion Device in Intracranial Arterial Aneurysm, sponsored by Nuvascular Inc. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Nuvascular Inc · Not applicable, Interventional, and Treatment

Updated Nov 2, 2026First site in AustriaNewly registered+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 79 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Intracranial Arterial Aneurysm
03

In context

Lead sponsor

Nuvascular Inc is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient must be 18-79 years of age at the time of screening.
  2. 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.
  3. The index IA to be treated must have the following characteristics:

    1. Saccular in shape/morphology
    2. Equatorial width 2 mm to 12 mm
    3. Absolute neck size ≥ 4mm and \< 7mm AND Dome-to-Neck (DN) ratio ≥1 OR Dome-to-Neck (DN) ratio 1 to 2
    4. IA is appropriate for treatment with the HARBOR Occlusion Device per device Instructions for Use
  4. Patient has an IA that is appropriate for treatment with HARBOR Occlusion Device without anticipated use of additional implanted devices
  5. Patient must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
  6. Patient or legally authorized representative must sign and date an IRB/EC-approved written prior to initiation of any study procedures.

    FOR PATIENTS WITH UNRUPTURED ANEURYSM

  7. 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

  8. Patient is neurologically stable with no seizure at the onset of the SAH, not requiring External Ventricular Drain (EVD) placement prior to inclusion
  9. 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).
  10. Patient must be neurologically stable with Hunt and Hess scale (HHS) of II or less at the time of treatment
  11. Patient must be mRS \< 2 prior to presentation or aneurysm rupture

Exclusion criteria

Exclusion Criteria:

  1. Patient has an IA with characteristics unsuitable for endovascular treatment.
  2. Microcatheter could not reach patient's index aneurysm to allow necessary access to treat with study device.
  3. Patient has vessel characteristics, tortuosity or morphology which could preclude safe access and support during treatment with study device;
  4. Patient has vascular disease or other vascular anomaly so as to preclude the necessary access to the aneurysm for use of the study device.
  5. Patient has clinical, angiographic or CT evidence of vasospasm, vasculitis, or intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
  6. Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as , minor strokes, or stroke-in-evolution within the prior 60 days.
  7. Patient has any circulatory, neurovascular, cardiovascular, or neurologic conditions that have resulted in unstable neurological symptoms.
  8. Patient has mRS > 3 prior to presentation
  9. 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.
  10. Patient's index IA was previously treated.
  11. Patient has a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
  12. Pregnant or breastfeeding women.
  13. Patient has known , 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.
  14. Patient is concurrently involved in another 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.
  15. Patient has an acute life-threatening illness other than the neurological disease to be treated in this trial.
  16. Patient has a of less than 2 years due to other illness or condition (in addition to an intracranial aneurysm).
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    HARBOR Occlusion Device

    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.

    Device: HARBOR Occlusion Device

Interventions

  • DeviceHARBOR Occlusion Device

    The HARBOR Occlusion Device is a self-expanding braided nitinol implant delivered through a microcatheter for endovascular treatment of intracranial aneurysms.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year after treatment (10-14 months)

  2. 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.

    Time frame: 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.

    Time frame: 1 year after treatment (10-14 months)

07

Study locations

2 sites
  • Christian-Doppler-Klinik Salzburg / University Clinic for Neurology of the PMU / Institute for Neurointervention
    Salzburg, Austria
  • University Hospital St. Ivan Rilski
    Sofia, Bulgaria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2027, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 28, 2026
StartEst.
Oct 26, 2026
Primary completionEst.
Dec 18, 2027
CompletionEst.
Dec 18, 2028
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added — first site in Austria
Show site
  • Christian-Doppler-Klinik Salzburg / University Clinic for Neurology of the PMU / Institute for Neurointervention · Salzburg, Austria
Nov 2, 2026
Registered
First appeared on the registry
Oct 28, 2026
Show all 2 updates
  1. Nov 2, 2026
    1 site added — first site in Austria
    Show site
    • Christian-Doppler-Klinik Salzburg / University Clinic for Neurology of the PMU / Institute for Neurointervention · Salzburg, Austria
  2. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07900464
Lead sponsor
Nuvascular Inc
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Oct 26, 2026 (estimated)
Primary completion
Dec 18, 2027 (estimated)
Completion
Dec 18, 2028 (estimated)
Last update
Nov 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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