A Medical Device to Treat Wide-Neck Brain Aneurysms

NCT05550571 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLD-329(US)
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 5

Brief Summary

The study aims to evaluate the safety and probable benefit of a medical device to treat wide-neck ruptured brain aneurysms.

Conditions

Ruptured Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• The proportion of subjects with complete aneurysm occlusion

  12 months

• device-related Serious Adverse Event

  12 months

• aneurysm occlusion at the conclusion of the treatment procedure

  During procedure

• Distribution of parent vessel compromise

  12 months

• Coil/Device entanglement

  During procedure

Study Arms (1)

Patients treated with the device

EXPERIMENTAL

Device: Nautilus Intrasaccular Bridging System

Interventions

Nautilus Intrasaccular Bridging System DEVICE

Patients will be treated with the Nautilus, then followed-up for 12 months

Patients treated with the device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 years old
• Subject who presents with an angiographically confirmed, wide neck intracranial saccular, acutely ruptured aneurysm. Wide neck is defined as 4-7mm.
• Aneurysm dome ≥5 mm.
• Subject is neurologically stable with a Hunt \& Hess score of I, II, or III.
• In the opinion of the treating physician, placement of the Nautilus is technically feasible and clinically reasonable.
• The subject or authorized representative is able to provide informed consent and has signed the IRB-approved informed consent form.
• Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.

You may not qualify if:

• 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:
• 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
• 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.

Sponsors & Collaborators

• EndoStream Medical: lead

Study Sites (5)

Baptist Health Ambulatory Services, Inc. d/b/a/ Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

University of South Florida

Tampa, Florida, 33620, United States

Location

The research Foundation For The State Of New York On Behalf Of The University At Buffalo

Buffalo, New York, 14203, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

UMHAT "Sv. Ivan Rilski" EAD

Sofia, Sofia, 000715054, Bulgaria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: September 22, 2022
• Study Start: December 17, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); BU (1)