Cerebral Aneurysm
Conditions
Brief summary
An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. Most brain aneurysms only cause noticeable symptoms if they burst (rupture). This leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms. The study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.
Detailed description
Patients will be treated with the Nautilus, then will be followed up for up to 6 months.
Interventions
DEVICENautilus endovascular device
Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months
Sponsors
EndoStream Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\* Patients who present with intracranial aneurysm
Exclusion criteria
\* Unstable neurological deficit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 3-6 months | The rate of participants experiencing death or stroke in treated vascular territory measured using the NIH stroke scale within 3- 6 months follow-up |
| Probable benefit | 3-6 months | Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up |
Countries
Bulgaria, Latvia
Outcome results
None listed