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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with the device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nautilus Intrasaccular Bridging System | Device | Patients will be treated with the Nautilus, then followed-up for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| device-related Serious Adverse Event |
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Inclusion Criteria:
Exclusion Criteria:
Subject with any neurological deficit occurred within the last 180 days; defined as previous non-aneurysmal subarachnoid hemorrhage or any other non-aneurysmal intracranial hemorrhage, stroke, transient ischemic attacks (TIA), concussion, head trauma, cranial surgery, radiation therapy to the head.
Premorbid mRS score ≥3.
Subject has another aneurysm which, in the Investigator's opinion, will require treatment within the follow-up period (1 year).
Women of child-bearing potential age (18-55) who cannot provide a negative pregnancy test.
Subject with other serious comorbidities that carry a high risk of neurologic events such as:
Severe or unstable conditions or diseases (e.g., non-significant neurological deficit, cancer, hematologic or coronary disease) or chronic conditions that in the opinion of the investigator may increase the risk associated with study participation for study device administration or may interfere with the interpretation of study results.
Extreme vessel stenosis or tortuosity or other vascular anomalies that would prevent delivery of the device to the target.
Comorbidities that may preclude obtaining follow-up DSA.
Known allergy to Nickel and/or Heparin that cannot be medically treated.
Subject is currently participating in another interventional clinical study.
Subject with a relative contraindication to angiography (i.e., allergy to contrast media, coagulopathy, etc.)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health Ambulatory Services, Inc. d/b/a/ Baptist Health Research Institute | Jacksonville | Florida | 32207 | United States | ||
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Proportion of subjects with a device-related Serious Adverse Event |
| 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) | During procedure |
| Distribution of parent vessel compromise | The percentage of parent vessel compromise will be evaluated by treating physician | 12 months |
| Coil/Device entanglement | Proportion of events of Coil/Nautilus entanglement during implantation which precludes the coil from being removed or adjusted | During procedure |
| Technical Success | Device placement success rate | During procedure |
| University of South Florida |
| Tampa |
| Florida |
| 33620 |
| United States |
| The research Foundation For The State Of New York On Behalf Of The University At Buffalo | Buffalo | New York | 14203 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| UMHAT "Sv. Ivan Rilski" EAD | Sofia | Sofia | 000715054 | Bulgaria |