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
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.
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.
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.
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.
The index IA to be treated must have the following characteristics:
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
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
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The HARBOR Occlusion Device is a self-expanding braided nitinol implant delivered through a microcatheter for endovascular treatment of intracranial aneurysms.
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)
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).
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)
Plan to share: No
No publications or documents are linked to this record.
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.
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 ↗
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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