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Intracranial AneurysmPhase 3SEAL™ITNCT05831202

SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial

A Phase 3 study testing The SEAL™ Saccular Endovascular Aneurysm Lattice System in people with Intracranial Aneurysm, run by Galaxy Therapeutics INC at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms. The data from this study will be used to support a premarket approval (PMA) submission. Read more about this study

Who is it for?
Ages 22 to 80 years
Conditions the study is for
Intracranial Aneurysm
What is being tested?
The SEAL™ Saccular Endovascular Aneurysm Lattice System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
279 participants
Where
6 sitesUnited States
Study dates
6 Aug 2024to 10 Sep 2030
Phase
Phase 3
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 22 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 22 to 80 years of age at the time of screening.
  • Unruptured aneurysm requiring endovascular treatment suitable for SEAL device and meet the American Heart Association (AHA) guidelines for management of unruptured aneurysm.5
  • Ruptured aneurysm A ruptured aneurysm is 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. Ruptured aneurysm may be included according to the following criteria:
  • The subject is neurologically stable with no seizure at the onset of the SAH, not requiring External Ventricular Drain (EVD) placement prior to inclusion.
  • Hunt and Hess scale (HHS) of 2 or less at the time of treatment.
  • mRS of ≤2 prior to presentation or aneurysm rupture.
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  • Meet the AHA guidelines for management of ruptured aneurysm.
  • The index intracranial aneurysm (IA) to be treated must include the following features:
  • Group A (primary analysis group): The Terminus/ bifurcation location:
  • 2 mm to 19 mm in equatorial aneurysm width wide neck aneurysm:
  • Absolute neck size ≥ 4mm and < 9mm AND Dome-to-Neck (DN) ratio ≥1 OR Dome- to-Neck (DN) ratio 1 to 2
  • Saccular morphology
  • Located in the anterior or posterior circulation
  • Group B (Expanded Indication): The Sidewall location:
  • 2 mm to 19 mm in equatorial aneurysm width wide neck aneurysm:
  • Absolute neck size ≥ 4mm and < 9mm AND Dome-to-Neck (DN) ratio ≥1 OR Dome- to-Neck (DN) ratio 1 to 2
  • Saccular morphology
  • Located in the anterior or posterior circulation
  • Aneurysm treatment does not require the preplanned use of any additional implanted devices.
  • Subject is able to maintain compliance with all aspects of screening, evaluation, treatment, and post-procedure follow-up schedule.
  • Baseline pre-procedure mRS of 0-2 for unruptured aneurysm and 0-2 prior to the SAH for the ruptured aneurysms.
  • Ability to obtain written informed consent document (ICD) subject or legally authorized representative in SAH subjects prior to the initiation of any study procedures.

Who cannot join

  • Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.
  • Aneurysms smaller than 2 mm and larger than 19 mm in dome width.
  • Patients with untreated multiple aneurysms [≥2mm]. Patient with multiple aneurysms, should have the none index aneurysms treated no less than 60 days prior to enrollment in the SEAL™ IT trial, ≤ 7mm, and not treated with flow diverter or stent assisted endovascular therapy.
  • Inability to access target aneurysm with microcatheter due to intracranial atherosclerosis, proximal or intracranial vessel tortuosity or poor aneurysm angle take-off.
  • Patients with two 360 degrees loops in the carotid or vertebral arteries.
  • Presence of vascular disease or other vascular abnormality that could prohibit access to index aneurysm such carotid stenosis or diminished caliber of the target artery.
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  • Clinical, angiographic, or CT evidence of central nervous system (CNS) arterial vasculitis, Moyamoya disease, intracranial tumor (except small meningioma < 3 cm), or any other intracranial vascular malformations.
  • Patients with high risk for recurrent ischemic stroke due to previous history of ischemic stroke symptoms such as TIAs, minor, or major strokes within the past 60 days. Other stroke risk factors such as intracranial stenosis or atrial fibrillation.
  • Patients with hemodynamic or medical compromise due to medical comorbidities such as severe unstable congestive heart failure (ejection fraction <30%) or severe chronic obstructive pulmonary disease (COPD) requiring home oxygen.
  • Target index aneurysm that has been previously treated and contains devices, implants, or coils that could interfere with correct SEAL™ device placement.
  • Subject is pregnant or a lactating female (For females of child-bearing potential, a positive pregnancy test within 7 days of the day of procedure or refusal to use a medically accepted method of birth control for the duration of the study.
  • Currently on anticoagulation therapy or has a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
  • Currently enrolled in another investigational study or post-market study that could affect the safety and efficacy of aneurysm treatment or interfere with the study follow-up schedule.
  • Presence of an acute life-threatening illness requiring treatment.
  • Life expectancy of < 5 years.
  • Subject has an uncontrolled co-morbid medical, neurological, or psychiatric condition, that would adversely affect participation in the study procedures and follow up.
  • Patient with chronic kidney disease (and not on dialysis) with creatinine > 2.0.
  • Subject with a known, uncontrolled hypersensitivity to iodine-based contrast dye, procedure related materials or medications, or device components^
  • Subject is a prisoner or member of other vulnerable population.
  • The subject that is in the opinion of the treating interventionalist is not suitable for the study.
  • Subjects with history of intracranial bleeding (SAH, SDH or ICH) within 90 days of the index aneurysm treatment.
  • Sensitivity to nickel is not specifically excluded, GTI performed ASTM F2129 testing recommended by the FDA in its 2015 and 2019 guiding documents. GTI results from the testing indicated that SEALTM meets the acceptance criteria that there is a high probability that the margin of safety against pitting (Eb-Er) is 200mV or higher, therefore, with high confidence, no further testing is required. The IFU contains the following precaution: "For patients with known hypersensitivity or allergic reaction to the implant components such as titanium or to nickel, use of the SEALTM System may lead to allergic reaction and user should counsel the patient on the device components".

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Endeavor Health - Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • The Cooper Health System

    Camden, New Jersey, 08103

  • Endeavor Health - Evanston Hospital

    Evanston, Illinois, 60201

  • Endeavor Health- Edward Hospital

    Naperville, Illinois, 60540

  • NYU Langone Health

    New York, New York, 10016

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

Other trials in United States

About this study

To establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms.

The data from this study will be used to support a premarket approval (PMA) submission.

Read the detailed description

Prospective, United States (US) and Outside of the United States (OUS) single-arm, multicenter, interventional study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 19 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System. Immediate post-procedure angiographic findings, clinical presentation, safety, and optional imaging follow-up for each subject will be collected at 24 hours or discharge, 3 months, 6 months, and required primary end point 12 months post-procedure. Digital subtraction angiography (DSA) at 12 months will be required imaging for the primary effectiveness endpoint assessment. After the PMA application, subjects follow up will continue annually for a total of five years post procedure.

Being tested
The SEAL™ Saccular Endovascular Aneurysm Lattice System
Keywords
Interventional Neurology, Intrasaccular Flow Diversion
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The SEAL™ Saccular Endovascular Aneurysm Lattice SystemDevice

    All adult subjects between 22 and 80 years of age and presenting with an unruptured or ruptured saccular Wide Neck intracranial aneurysm with less or equal to 19 mm in its equatorial width (2mm-19mm range) that in the opinion of the Principal Investigator (PI) requires treatment and suitable candidate for intrasaccular flow diversion treatment, who meet all eligibility criteria, will be considered for study enrollment.

Study groups in NCT05831202
Study groupRoleWhat they receive
Single arm (The SEAL™ Saccular Endovascular Aneurysm Lattice System)OtherProspective, US and OUS single-arm, multicenter, interventional study.
Receives: Device: The SEAL™ Saccular Endovascular Aneurysm Lattice System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with successful aneurysm occlusion at 12 months

    Proportion of subjects with successful aneurysm occlusion at 12 months without parent artery stenosis or retreatment, as determined by independent core lab.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start6 Aug 2024
  3. Primary completion10 Sep 2026 (estimated)
  4. Study completion10 Sep 2030 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
279 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05831202
Sponsor's protocol ID
TP0081
Acronym
SEAL™IT
Status last verified
Jan 2026
First submitted
14 Apr 2023
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing The SEAL™ Saccular Endovascular Aneurysm Lattice System in people with Intracranial Aneurysm, run by Galaxy Therapeutics INC at 6 sites in United States.

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 22 inclusion and 22 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Proportion of subjects with successful aneurysm occlusion at 12 months (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05831202.

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 16 Jan 2026.

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