The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio \<2) or fusiform intracranial aneurysms in the internal carotid artery (ICA) from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.5 mm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Implantation of the World Diverter Embolization Device
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Primary Safety - Major Adverse Events (MAEs)
Composite incidence of the following events: * Major stroke (NIHSS increase of \> 4) within 30 days post-procedure, defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting \> 24 hours with no apparent cause other than of vascular origin, including ischemic stroke or hemorrhagic stroke \[i.e., intraparenchymal hemorrhage (IPH), subarachnoid hemorrhage (SAH), subdural hemorrhage (SDH), epidural hemorrhage (EDH)\] accompanied with radiological evidence * Major ipsilateral stroke within 12 months post-procedure, defined as a major stroke (as defined above) occurring within the vascular distribution of the target artery * Neurological death within 12 months, defined as a death which directly resulted from a neurologic cause.
Time frame: 12 months
Primary Effectiveness - Complete Occlusion
The proportion of subjects with all of the following: * Complete (100%) occlusion of the target IA (Raymond-Roy Class I) * ≤ 50% stenosis of the parent artery at the target IA assessed by an independent Core Laboratory evaluation of angiography at 12 months post-procedure * No subsequent treatment of the target IA within 12 months post-procedure.
Time frame: 12 months
Medium-Term Effectiveness
Complete IA occlusion
Time frame: 6 months
Medium-Term Parent Artery Stenosis
Parent Artery Stenosis
Time frame: 6 months
Medium-Term Functional Outcomes
Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline
Time frame: 6 months
Secondary Effectiveness - Adequate Occlusion
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The proportion of subjects with all of the following: * Adequate occlusion of the target IA (Raymond-Roy Class I or II) * ≤ 50% stenosis of the parent artery at the target IA assessed by an independent Core Laboratory evaluation of angiography 12 months post-procedure * No subsequent treatment of the target IA within 12 months post-procedure
Time frame: 12 months
Long-Term Angiographic Outcome
Raymond-Roy IA classifications
Time frame: 12 months
Long-Term Parent Artery Stenosis
Parent Artery Stenosis
Time frame: 12 months
Long-Term Functional Outcome
Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline
Time frame: 12 months