ACTIVE_NOT_RECRUITING

A Medical Device to Treat Wide-Neck Brain Aneurysms

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Treatment of Ruptured Wide-Neck Aneurysms With Nautilus Device Assisted Occlusion

Quick Facts

Study Start:2022-12-17

Study Completion:2026-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05550571

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.)

Inclusion Criteria

Exclusion 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.

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.)

Contacts and Locations

Study Locations (Sites)

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

Jacksonville, Florida, 32207

United States

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

Collaborators and Investigators

Sponsor: EndoStream Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-17

Study Completion Date2026-10-01

Study Record Updates

Study Start Date2022-12-17

Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

Ruptured Cerebral Aneurysm