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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05880680




Registration number
NCT05880680
Ethics application status
Date submitted
19/05/2023
Date registered
30/05/2023

Titles & IDs
Public title
SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry
Scientific title
SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry
Secondary ID [1] 0 0
TP0050
Universal Trial Number (UTN)
Trial acronym
SEAL™ME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aneurysm 0 0
Aneurysm, Ruptured 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - SEAL Device

Treatment: Devices: SEAL Device
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with successful aneurysm occlusion at 12 months without parent artery stenosis or retreatment, as determined by independent core lab.
Timepoint [1] 0 0
12 Months

Eligibility
Key inclusion criteria
1. 18 to 80 years of age at the time of screening.
2. 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.
3. Ruptured aneurysm

1. 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.
2. Hunt and Hess scale of 3 or less at the time of treatment.
3. Modified Disability Scale (mRS) of =2 prior to presentation or aneurysm rupture.
4. Meet the AHA guidelines for management of ruptured aneurysm.6
4. The index intracranial aneurysm (IA) to be treated must include the following features:

1. Aneurysm features suitable for endovascular treatment with an intrasaccular device per the treating interventionist.
2. Saccular morphology.
3. Located at a bifurcation, terminus, or sidewall in the anterior or posterior circulation.
4. 2.5 mm-20 mm in dome diameter.
5. Wide-neck aneurysm with neck size = 4mm or Dome-to-Neck (DN) ratio < 2.
5. Aneurysm treatment does not require the preplanned use of any additional implanted devices.
6. Subject is able to maintain compliance with all aspects of screening, evaluation, treatment, and post-procedure follow-up schedule.
7. Baseline pre-procedure mRS of 0-2 for unruptured aneurysm and 0-2 prior to the SAH for the ruptured aneurysms.
8. Ability to obtain written informed consent from subject or legally authorized representative in SAH subjects prior to the initiation of any study procedures.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.
2. Aneurysms smaller than 2.5 mm and larger than 20 mm in dome width.
3. Inability to access target aneurysm with microcatheter due to intracranial atherosclerosis, proximal or intracranial vessel tortuosity or poor aneurysm angle take-off.
4. Patients with two 360 degrees loops in the carotid or vertebral arteries.
5. 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.
6. Clinical, angiographic, or CT evidence of CNS arterial vasculitis, Moyamoya disease, intracranial tumor (except small meningioma), or any other intracranial vascular malformations.
7. 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.
8. 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.
9. Modified Rankin Scale (mRS) score of > 2 prior to presentation.
10. Target index aneurysm that has been previously treated and contains devices, implants, or coils that could interfere with correct SEAL™ device placement.
11. 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.
12. Currently on anticoagulation therapy or has a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
13. 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.
14. Presence of an acute life-threatening illness requiring treatment.
15. Life expectancy of <1 year.
16. Subject has an uncontrolled co-morbid medical condition, that would adversely affect participation in the study.
17. Patient with chronic kidney disease (and not on dialysis) with creatinine > 2.0.
18. Subject is a prisoner or member of other vulnerable population.
19. 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".

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/06/2030
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Medellín
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
Pakistan
State/province [3] 0 0
Lahore
Country [4] 0 0
Spain
State/province [4] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galaxy Therapeutics INC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Osama Zaidat, MD, MS
Address 0 0
Mercy Health, OH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Osama O Zaidat, MD, MS
Address 0 0
Country 0 0
Phone 0 0
12627515899
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05880680