To establish the preliminary safety and effectiveness of the SEAL™ Endovascular Aneurysm Lattice System for the treatment of saccular intracranial aneurysms. The data from this study will be used to support: 1. EU CE Mark labelling 2. US FDA Investigational Device Exemption (IDE) approval support of PMA approval.
First In Human (FIH), prospective, single-arm, multicenter, interventional study. Patients presenting with evidence of a single unruptured or ruptured aneurysm requiring treatment will be enrolled into the study and treated using the SEAL™ System. Immediate post-procedure angiographic findings, clinical presentation, safety, and imaging follow-up for each subject will be collected at 24 hours, 3 (MRA), 6, 12 and 24-months post-procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Endovascular treatment of target aneurysm using the Saccular Endovascular Aneurysm Lattice (SEAL) device.
Clinicas Las Americas
Medellín, Antioquia, Colombia
Primary Safety Endpoint
Subject Safety will be considered a failure upon meeting any of the following primary safety criteria: * Any stroke within 72 hours of the procedure or discharge home (if earlier) that results in an increase of 4 or more points on the National Institute of Health Stroke Scale * Major ipsilateral stroke within 72 hours post-procedure or discharge home (if earlier) to 12-months following treatment * New subarachnoid hemorrhage related to target aneurysm within 72 hours post-procedure or discharge home (if earlier) to 12-months following treatment * Death due to neurologic cause related to aneurysm treated from Procedure to 12-months following treatment
Time frame: Procedure through 12 Months
Primary Efficacy Endpoint
Proportion of subjects with aneurysm occlusion adjudicated by independent core lab based on satisfaction of the following 3 criterion: * WEB-IT Occlusion Scale I and II (WOS) post-implantation, at 6 months, and at 12 months * Raymond Roy Scale I (RRS) post-implantation, at 6 months, and at 12 months * Technical success defined as the proportion of subjects in whom a SEAL™ System was successfully delivered and deployed at the target aneurysm
Time frame: Procedure through 12 Months
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