A Medical Device to Treat Brain Aneurysms
- Conditions
- Cerebral Aneurysm
- Interventions
- Device: Nautilus endovascular device
- Registration Number
- NCT04963933
- Lead Sponsor
- EndoStream Medical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
* Patients who present with intracranial aneurysm
* Unstable neurological deficit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients treated with the device Nautilus endovascular device Patients treated with the Nautilus will be followed up
- Primary Outcome Measures
Name Time Method Probable benefit 3-6 months Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
St. Ivan Rilski University hospital
🇧🇬Sofia, Bulgaria
Paula Stradina university hospital
🇱🇻Riga, Latvia