NECC
Brief description of study
The objective of this trial is to obtain clinical data to demonstrate that the Contour Neurovascular System is safe and effective for the treatment of wide-necked bifurcated saccular, intracranial aneurysms PRIMARY SAFETY ENDPOINT: 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.
PRIMARY EFFECTIVENESS ENDPOINT:
Complete occlusion of the aneurysm with Contour as defined by complete aneurysm occlusion (Raymond Roy Scale3,4 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 trials secondary endpoint is the proportion of subjects with angiographic aneurysmal recurrence defined as aneurysm growth or recanalization at one (1) year after treatment.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Medical Research
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Age: - 99 Years
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Gender: All
TBD
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