The goal of this clinical trial is to collect additional data to demonstrate if the Contour Neurovascular System (CNS) is a safe and effective treatment of wide-necked, saccular, intracranial aneurysms. Participants will: Undergo treatment with the Contour Neurovascular System Complete follow-up visits at 1month, 12months, and 24 months, following their procedure Report any adverse events to their study team
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
The subject is brought into the procedure room, an angiogram on the day of the procedure indicates that the subject is anatomically eligible for the trial and any part of the investigational device comes in contact with the patient
University at Buffalo Neurosurgery
Buffalo, New York, United States
RECRUITINGStony Brook University
Stony Brook, New York, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGIncidence of death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year. Stroke is defined per the World Health Organization as: rapidly developing clinical signs of focal or global disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke.
Time frame: From enrollment to 1 year
Proportion of complete occlusion of the aneurysm with Contour, without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment.
Complete occlusion of the aneurysm with Contour as defined by complete aneurysm occlusion (Raymond Roy Scale of 1) without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis (\> 50% stenosis) at one (1) year after treatment as assessed by the angiographic core laboratory. The Raymond-Roy Scale grades aneurysms on a scale of one (1) to three (3) with a lower score correlating with a more favorable outcome. The Raymond-Roy Scale will be graded in accordance with the following definitions: Class 1 (Complete obliteration of the aneurysm), Class 2 (Persistence of any portion of the original defect of the arterial wall as seen on any single projection but without opacification of the aneurysmal sac), or Class 3 (Any opacification of the aneurysmal sac).
Time frame: From enrollment to 1 year
Incidence of Serious Adverse Events (SAE) associated with the procedure or device
Serious Adverse Events (SAE) associated with the procedure or device, both individually and in aggregate
Time frame: From enrollment to 2 years
Proportions of aneurysm occlusion ratings
·Detailed assessment of aneurysm occlusion from post procedure to one (1) year (and also at two (2) years for any aneurysm not completely occluded at 1 year) provided by the core lab review of the angiogram, including the following: * Complete occlusion (Raymond Roy Scale of 1) * Adequate Occlusion (Raymond Roy Scale of 1 or 2) * Raymond Roy scale The Raymond-Roy Scale grades aneurysms on a scale of one (1) to three (3) with a lower score correlating with a more favorable outcome. The Raymond-Roy Scale will be graded in accordance with the following definitions: Class 1 (Complete obliteration of the aneurysm), Class 2 (Persistence of any portion of the original defect of the arterial wall as seen on any single projection but without opacification of the aneurysmal sac), or Class 3 (Any opacification of the aneurysmal sac).
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Swedish Neuroscience Institute
Seattle, Washington, United States
RECRUITINGTime frame: From enrollment to 2 years
Incidence of stroke resulting in a disabling deficit
Assessment of incidence of stroke resulting in a disabling deficit, defined operationally as a deficit that, if unchanged, would prevent the patient from performing basic activities of daily living (i.e., bathing, ambulating, toileting, hygiene, and eating) or returning to work (mRS ≥ 3).
Time frame: From enrollment to 2 years
Incidence of serious neurological events
All serious neurological adverse events
Time frame: From enrollment to 2 years
Proportions of device movement ratings
·Detailed assessment of aneurysm occlusion from post procedure to one (1) year (and also at two (2) years for any aneurysm not completely occluded at 1 year) provided by the core lab review of the angiogram, including the following: o Device position (remains in place, migration into the parent artery or movement towards the aneurysm dome)
Time frame: From enrollment to 2 years