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

ConditionsAneurysm Aneurysm, Ruptured

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-80

SponsorGalaxy Therapeutics INC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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.

Time frame

12 Months