AneurysmSEAL™MENCT05880680
SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry
An observational study of Aneurysm and Aneurysm, Ruptured, run by Galaxy Therapeutics INC at 4 sites in 4 countries.
Trial summary
Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysm, Aneurysm, Ruptured
- What is being tested?
- SEAL Device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 9 Oct 2023to 15 Jun 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult subjects between 20 and 80 years of age and presenting with an unruptured or ruptured saccular Wide Neck intracranial aneurysm with less or equal to 20 mm in its widest diameter (2.5mm-20mm range) that in the opinion of the Principal Investigator requires treatment and suitable candidate for intrasaccular flow diversion treatment, who meet all eligibility criteria, will be considered for study enrollment. Up to 200 adult subjects will be enrolled in the study in up to 25 centers.
Who may be able to join
- 18 to 80 years of age at the time of screening.
- Unruptured aneurysm requiring endovascular treatment suitable for SEAL device and meet the AHA guidelines for management of unruptured aneurysm.5 If there is evidence of an additional aneurysm requiring treatment, the secondary aneurysm must also be treatable using a SEAL™ System Device, either during a single procedure or consecutive procedures.
- No additional preplanned implanted devices are permissible except for as medically required for patient safety during the procedure.
- Ruptured aneurysm
- Ruptured aneurysms may be included according to the following criteria: The subject is neurologically stable with no seizure at the onset of the SAH, not requiring EVD placement prior to inclusion.
- Hunt and Hess scale of 3 or less at the time of treatment.
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- Modified Disability Scale (mRS) of ≤2 prior to presentation or aneurysm rupture.
- Meet the AHA guidelines for management of ruptured aneurysm.6
- The index intracranial aneurysm (IA) to be treated must include the following features:
- Aneurysm features suitable for endovascular treatment with an intrasaccular device per the treating interventionist.
- Saccular morphology.
- Located at a bifurcation, terminus, or sidewall in the anterior or posterior circulation.
- 2.5 mm-20 mm in dome diameter.
- Wide-neck aneurysm with neck size ≥ 4mm or Dome-to-Neck (DN) ratio < 2.
- 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 from 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 2.5 mm and larger than 20 mm in dome width.
- 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.
- Clinical, angiographic, or CT evidence of CNS arterial vasculitis, Moyamoya disease, intracranial tumor (except small meningioma), or any other intracranial vascular malformations.
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- Patients with high risk for recurrent ischemic stroke due to previous history of ischemic stroke symptoms such as transient ischemic attacks (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 COPD requiring home oxygen.
- Modified Rankin Scale (mRS) score of > 2 prior to presentation.
- 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 <1 year.
- Subject has an uncontrolled co-morbid medical condition, that would adversely affect participation in the study.
- Patient with chronic kidney disease (and not on dialysis) with creatinine > 2.0.
- Subject is a prisoner or member of other vulnerable population.
- Subject that is in the opinion of the treating interventionalist is not suitable for the study.
- Sensitivity to nickel is not specifically excluded, Galaxy Therapeutics, Inc (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
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Colombia1 site, 1 recruiting
- Recruiting
Angiosur
Itagüi, Medellín
Margarita Cardozo, +573125722731, angiosur@gmail.com
Boris Pabon, MD, MS
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland, Auckland, 1023
Davina McAllister, +64274891940, davinams@adhb.govt.nz
James Caldwell, MD, MS
Pakistan1 site, 1 recruiting
- Recruiting
Punjab Institute of Neuroscience (PINS)
Lahore, Lahore
Naveed Majeed, MD, MS, +923334337575, drmnmlangha@gmail.com
Qasim Bashir, MD, MS
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Alejandro Tomasello, MD, MS, +34620660495, alejandrotomasello@gmail.com
Alejandro Tomasello, MD, MS
About this study
Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System.
Read the detailed description
Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 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. DSA at 12 months will be required imaging for the primary effectiveness endpoint assessment. Subjects follow up will continue annually for a total of five years post procedure.
- Conditions
- Aneurysm, Aneurysm, Ruptured
- Being tested
- SEAL Device
- Medical subject headings
- Aneurysm, Aneurysm, Ruptured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEAL DeviceDevice
Using standard interventional endovascular techniques, the device is navigated via the push wire delivery system through compatible neurovascular microcatheters to the aneurysm lumen or target site. The device is positioned into its target aneurysm lumen and is electrically detached by the operator with a hand-held, battery-powered detachment handle designed specifically for the SEAL Embolization System.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with successful aneurysm occlusion at 12 months without parent artery stenosis or retreatment, as determined by independent core lab.
- Index aneurysm occlusion is defined as achieving WEB Occlusion Scale (WOS) of A or B at 12 months.1,2
- Index aneurysm parent arterial stenosis is defined as diameter stenosis of >50%.
Index aneurysm retreatment at any point post procedure throughout the duration of the study period will be considered a failure for the primary efficacy endpoint.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start9 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Galaxy Therapeutics INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Osama Zaidat, MD, MS, Study chair, Mercy Health, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880680
- Sponsor's protocol ID
- TP0050
- Acronym
- SEAL™ME
- Status last verified
- Mar 2025
- First submitted
- 19 May 2023
- Last updated
- 4 Apr 2025
- 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry
- ClinicalTrials.gov ID
- NCT05880680
- Acronym / sponsor ID
- SEAL™ME / TP0050
- Conditions
- Aneurysm, Aneurysm, Ruptured
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Galaxy Therapeutics INCIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 30 May 2023 (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.
Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System.
Detailed description
Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 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. DSA at 12 months will be required imaging for the primary effectiveness endpoint assessment. Subjects follow up will continue annually for a total of five years post procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult subjects between 20 and 80 years of age and presenting with an unruptured or ruptured saccular Wide Neck intracranial aneurysm with less or equal to 20 mm in its widest diameter (2.5mm-20mm range) that in the opinion of the Principal Investigator requires treatment and suitable candidate for intrasaccular flow diversion treatment, who meet all eligibility criteria, will be considered for study enrollment. Up to 200 adult subjects will be enrolled in the study in up to 25 centers.
Key inclusion criteria (18 listed)
- 18 to 80 years of age at the time of screening.
- Unruptured aneurysm requiring endovascular treatment suitable for SEAL device and meet the AHA guidelines for management of unruptured aneurysm.5 If there is evidence of an additional aneurysm requiring treatment, the secondary aneurysm must also be treatable using a SEAL™ System Device, either during a single procedure or consecutive procedures.
- No additional preplanned implanted devices are permissible except for as medically required for patient safety during the procedure.
- Ruptured aneurysm
- The index intracranial aneurysm (IA) to be treated must include the following features:
Key exclusion criteria (20 listed)
- Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.
- Aneurysms smaller than 2.5 mm and larger than 20 mm in dome width.
- 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.
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 |
|---|---|---|
| SEAL DeviceUsing standard interventional endovascular techniques, the device is navigated via the push wire delivery system through compatible neurovascular microcatheters to the aneurysm lumen or target site. The device is positioned into its target aneurysm lumen and is electrically detached by the operator with a hand-held, battery-powered detachment handle designed specifically for the SEAL Embolization System. | Device | – |
Primary outcome
Proportion of subjects with successful aneurysm occlusion at 12 months without parent artery stenosis or retreatment, as determined by independent core lab.
Time frame: 12 Months
* Index aneurysm occlusion is defined as achieving WEB Occlusion Scale (WOS) of A or B at 12 months.1,2 * Index aneurysm parent arterial stenosis is defined as diameter stenosis of >50%. Index aneurysm retreatment at any point post procedure throughout the duration of the study period will be considered a failure for the primary efficacy endpoint.
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 4 Apr 2025.
- 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.
Osama Zaidat, MD, MS study chair
Mercy Health, OH
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm and Aneurysm, Ruptured, run by Galaxy Therapeutics INC at 4 sites in 4 countries.
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 18 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Colombia, New Zealand, Pakistan, Spain. 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?
Contact Osama O Zaidat, MD, MS (12627515899, szaidat@galaxytherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with successful aneurysm occlusion at 12 months without parent artery stenosis or retreatment, as determined by independent core lab. (time frame: 12 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 4 Apr 2025.