Actively Recruiting
SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry
Led by Galaxy Therapeutics INC · Updated on 2025-04-04
200
Participants Needed
4
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 80 years of age at the time of screening.
- Unruptured aneurysm requiring endovascular treatment suitable for the SEAL device and meeting AHA guidelines.
- Additional aneurysms requiring treatment must be treatable with the SEAL device during single or consecutive procedures.
- No additional preplanned implanted devices except if medically required for safety.
- Ruptured aneurysms may be included if neurologically stable with no seizures at SAH onset, no need for EVD placement before inclusion, Hunt and Hess scale 3 or less, and modified Rankin Scale (mRS) of 2 or less prior to presentation.
- Meet AHA guidelines for management of ruptured aneurysm.
- Index aneurysm must have saccular morphology, be located at bifurcation, terminus, or sidewall in anterior or posterior circulation, 2.5 to 20 mm dome diameter, and wide-neck (neck size 4 mm or larger or dome-to-neck ratio less than 2).
- Aneurysm treatment does not require preplanned use of other implanted devices.
- Ability to comply with screening, evaluation, treatment, and post-procedure follow-up.
- Baseline pre-procedure mRS of 0-2 for unruptured aneurysms and 0-2 prior to SAH for ruptured aneurysms.
- Ability to provide written informed consent or legally authorized representative consent for SAH subjects before study procedures.
You will not qualify if you...
- 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 or larger than 20 mm in dome width.
- Inability to access target aneurysm with microcatheter due to vessel conditions like atherosclerosis, tortuosity, or poor angle.
- Presence of two 360-degree loops in the carotid or vertebral arteries.
- Vascular diseases or abnormalities preventing access to aneurysm such as carotid stenosis or small caliber arteries.
- Evidence of CNS arterial vasculitis, Moyamoya disease, intracranial tumor (except small meningioma), or other intracranial vascular malformations.
- High risk for recurrent ischemic stroke or stroke symptoms within past 60 days.
- Severe unstable congestive heart failure or severe COPD requiring home oxygen.
- Modified Rankin Scale score greater than 2 prior to presentation.
- Previously treated index aneurysm containing implants, devices, or coils interfering with SEAL device placement.
- Pregnancy or lactation; refusal to use accepted birth control if of child-bearing potential.
- Current anticoagulation therapy or blood disorders.
- Enrollment in conflicting investigational or post-market studies.
- Acute life-threatening illness requiring treatment.
- Life expectancy less than 1 year.
- Uncontrolled comorbid medical conditions affecting study participation.
- Chronic kidney disease with creatinine over 2.0 (not on dialysis).
- Prisoners or other vulnerable populations.
- Investigator opinion of unsuitability for the study or known hypersensitivity to device components requiring counseling.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Angiosur
Itagüi, Medellín, Colombia
Actively Recruiting
2
Auckland City Hospital
Auckland, Auckland, New Zealand, 1023
Actively Recruiting
3
Punjab Institute of Neuroscience (PINS)
Lahore, Lahore, Pakistan
Actively Recruiting
4
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
Research Team
O
Osama O Zaidat, MD, MS
CONTACT
S
Sergi López García
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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