SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry

NCT05880680 | Recruiting DMC

• 1 other identifier: TP0050
• Study Type: observational
• Target: 200
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Aneurysm; Aneurysm, Ruptured

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Months

Interventions

SEAL Device 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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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
• Hunt and Hess scale of 3 or less at the time of treatment.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Galaxy Therapeutics INC: lead

Study Sites (4)

Angiosur

Itagüi, Medellín, Colombia

RECRUITING

Auckland City Hospital

Auckland, Auckland, 1023, New Zealand

RECRUITING

Punjab Institute of Neuroscience (PINS)

Lahore, Lahore, Pakistan

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Aneurysm; Aneurysm, Ruptured

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Osama Zaidat, MD, MS

  Mercy Health, OH

  STUDY CHAIR

Central Study Contacts

Osama O Zaidat, MD, MS

CONTACT

12627515899; szaidat@galaxytherapeutics.com

Sergi López García

CONTACT

+34690926013; sergi@gtseal.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 30, 2023
• Study Start: October 9, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 15, 2030
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); PA (1); ES (1); CO (1)