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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.
Patients will be treated with the Nautilus, then will be followed up for up to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with the device | Experimental | Patients treated with the Nautilus will be followed up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nautilus endovascular device | Device | Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | The rate of participants experiencing death or stroke in treated vascular territory measured using the NIH stroke scale within 3- 6 months follow-up | 3-6 months |
| Probable benefit | Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up | 3-6 months |
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Inclusion Criteria:
* Patients who present with intracranial aneurysm
Exclusion Criteria:
* Unstable neurological deficit
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Ivan Rilski University hospital | Sofia | 1431 | Bulgaria | |||
| Paula Stradina university hospital |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Riga |
| LV-1002 |
| Latvia |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |