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
Patient is 18-75 years of age at the time of screening.
Patient has a single ruptured or unruptured IA requiring treatment. If the patient has an additional IA requiring treatment, the additional IA must not require treatment within 60 days after the index procedure.
Saccular morphology
Located at a bifurcation in the anterior or posterior circulation
Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device
Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device.
Contraindication to anticoagulants or anti-platelet medications
Single group
Contour Neurovascular System Treatment Attempt
DeviceThe 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
Incidence 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.
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).
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
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).
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).
Incidence of serious neurological events
All serious neurological adverse events
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