A Medical Device to Treat Brain Aneurysms
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
Patients will be treated with the Nautilus, then will be followed up for up to 6 months.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Patients treated with the device Patients treated with the Nautilus will be followed up |
Device: Nautilus endovascular device
Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients who present with intracranial aneurysm
Exclusion Criteria:
- Unstable neurological deficit
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | St. Ivan Rilski University hospital | Sofia | Bulgaria | 1431 | |
2 | Paula Stradina university hospital | Riga | Latvia | LV-1002 |
Sponsors and Collaborators
- EndoStream Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLD-262