Ruptured Cerebral Aneurysm
Conditions
Brief summary
The study aims to evaluate the safety and probable benefit of a medical device to treat wide-neck ruptured brain aneurysms.
Detailed description
Patients with ruptured brain aneurysms will be treated with the Nautilus, then will be followed up for one year.
Interventions
DEVICENautilus Intrasaccular Bridging System
Patients will be treated with the Nautilus, then followed-up for 12 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
1. Subject is ≥18 years old 2. Subject who presents with an angiographically confirmed, wide neck intracranial saccular, acutely ruptured aneurysm. Wide neck is defined as 4-7mm. 3. Aneurysm dome ≥5 mm. 4. Subject is neurologically stable with a Hunt & Hess score of I, II, or III. 5. In the opinion of the treating physician, placement of the Nautilus is technically feasible and clinically reasonable. 6. The subject or authorized representative is able to provide informed consent and has signed the IRB-approved informed consent form. 7. Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
Exclusion criteria
1. 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. 2. Premorbid mRS score ≥3. 3. Subject has another aneurysm which, in the Investigator's opinion, will require treatment within the follow-up period (1 year). 4. Women of child-bearing potential age (18-55) who cannot provide a negative pregnancy test. 5. Subject with other serious comorbidities that carry a high risk of neurologic events such as: * Significant acute or chronic cardiovascular disease such as myocardial infarction within the past 180 days * Uncorrectable coagulation abnormality * Uncontrolled diabetes mellitus with target organ injury * Organ failure of kidney, liver, heart or lungs * Arteriovenous malformation or arteriovenous fistula, Moyamoya disease, or any other vasoconstriction * Premorbid intracranial tumor or hematoma 6. 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. 7. Extreme vessel stenosis or tortuosity or other vascular anomalies that would prevent delivery of the device to the target. 8. Comorbidities that may preclude obtaining follow-up DSA. 9. Known allergy to Nickel and/or Heparin that cannot be medically treated. 10. Subject is currently participating in another interventional clinical study. 11. Subject with a relative contraindication to angiography (i.e., allergy to contrast media, coagulopathy, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects experiencing death or stroke | 12 months | The proportion of subjects experiencing death or stroke in treated vascular territory measured using the NIH stroke scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| device-related Serious Adverse Event | 12 months | Proportion of subjects with a device-related Serious Adverse Event |
| aneurysm occlusion at the conclusion of the treatment procedure | During procedure | Proportion of subjects with aneurysm occlusion at the conclusion of the treatment procedure (assessed via the Raymond Roy scale) |
| The proportion of subjects with complete aneurysm occlusion | 12 months | The proportion of subjects with complete aneurysm occlusion (defined as Raymond Roy scale =1) without retreatment at 1-year follow-up imaging |
| Coil/Device entanglement | During procedure | Proportion of events of Coil/Nautilus entanglement during implantation which precludes the coil from being removed or adjusted |
| Technical Success | During procedure | Device placement success rate |
| Distribution of parent vessel compromise | 12 months | The percentage of parent vessel compromise will be evaluated by treating physician |
Countries
Bulgaria, United States
Outcome results
None listed