A Medical Device to Treat Wide-Neck Brain Aneurysms

Not Applicable

Active, not recruiting

• Conditions: Ruptured Cerebral Aneurysm
• Interventions: Device: Nautilus Intrasaccular Bridging System

• Registration Number: NCT05550571
• Lead Sponsor: EndoStream Medical

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.

Study Timeline

• Study First Submitted: 2022-09-11
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Study Start: 2022-12-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-07-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients treated with the device	Nautilus Intrasaccular Bridging System	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
device-related Serious Adverse Event	12 months	Proportion of subjects with a device-related Serious Adverse Event
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
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
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)
Coil/Device entanglement	During procedure	Proportion of events of Coil/Nautilus entanglement during implantation which precludes the coil from being removed or adjusted

Trial Locations

Locations (5)

UMHAT "Sv. Ivan Rilski" EAD; 🇧🇬 Sofia, Bulgaria

Baptist Health Ambulatory Services, Inc. d/b/a/ Baptist Health Research Institute; 🇺🇸 Jacksonville, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

The research Foundation For The State Of New York On Behalf Of The University At Buffalo; 🇺🇸 Buffalo, New York, United States

Mount Sinai; 🇺🇸 New York, New York, United States