The study aims to evaluate the safety and probable benefit of a medical device to treat wide-neck ruptured brain aneurysms.
Patients with ruptured brain aneurysms will be treated with the Nautilus, then will be followed up for one year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Patients will be treated with the Nautilus, then followed-up for 12 months
Baptist Health Ambulatory Services, Inc. d/b/a/ Baptist Health Research Institute
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
The research Foundation For The State Of New York On Behalf Of The University At Buffalo
Buffalo, New York, United States
Mount Sinai
New York, New York, United States
The proportion of subjects experiencing death or stroke
The proportion of subjects experiencing death or stroke in treated vascular territory measured using the NIH stroke scale
Time frame: 12 months
The proportion of subjects with complete aneurysm occlusion
The proportion of subjects with complete aneurysm occlusion (defined as Raymond Roy scale =1) without retreatment at 1-year follow-up imaging
Time frame: 12 months
device-related Serious Adverse Event
Proportion of subjects with a device-related Serious Adverse Event
Time frame: 12 months
aneurysm occlusion at the conclusion of the treatment procedure
Proportion of subjects with aneurysm occlusion at the conclusion of the treatment procedure (assessed via the Raymond Roy scale)
Time frame: During procedure
Distribution of parent vessel compromise
The percentage of parent vessel compromise will be evaluated by treating physician
Time frame: 12 months
Coil/Device entanglement
Proportion of events of Coil/Nautilus entanglement during implantation which precludes the coil from being removed or adjusted
Time frame: During procedure
Technical Success
Device placement success rate
Time frame: During procedure
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UMHAT "Sv. Ivan Rilski" EAD
Sofia, Sofia, Bulgaria