SEALâ„¢IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial
United States279 participantsStarted 2024-08-06
Plain-language summary
To establish the safety and effectiveness of the SEALâ„¢ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms.
The data from this study will be used to support a premarket approval (PMA) submission.
Who can participate
Age range22 Years – 80 Years
SexALL
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Inclusion criteria
✓. 22 to 80 years of age at the time of screening.
✓. Unruptured aneurysm requiring endovascular treatment suitable for SEAL device and meet the American Heart Association (AHA) guidelines for management of unruptured aneurysm.5
✓. Ruptured aneurysm A ruptured aneurysm is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of Subarachnoid Hemorrhage (SAH) attributed to the index aneurysm within the last 60 days. Ruptured aneurysm may be included according to the following criteria:
✓. The index intracranial aneurysm (IA) to be treated must include the following features:
✓. 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 document (ICD) subject or legally authorized representative in SAH subjects prior to the initiation of any study procedures.
Exclusion criteria
✕. Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.
✕. Aneurysms smaller than 2 mm and larger than 19 mm in dome width.
What they're measuring
1
Proportion of subjects with successful aneurysm occlusion at 12 months
✕. Patients with untreated multiple aneurysms \[≥2mm\]. Patient with multiple aneurysms, should have the none index aneurysms treated no less than 60 days prior to enrollment in the SEAL™ IT trial, ≤ 7mm, and not treated with flow diverter or stent assisted endovascular therapy.
✕. 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 central nervous system (CNS) arterial vasculitis, Moyamoya disease, intracranial tumor (except small meningioma \< 3 cm), or any other intracranial vascular malformations.
✕. Patients with high risk for recurrent ischemic stroke due to previous history of ischemic stroke symptoms such as TIAs, minor, or major strokes within the past 60 days. Other stroke risk factors such as intracranial stenosis or atrial fibrillation.