A Medical Device to Treat Wide-Neck Brain Aneurysms

Ruptured Cerebral Aneurysm Clinical Trial

— TORNADO-US  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05550571
• Other study ID #: CLD-329(US)
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2022
• Est. completion date: March 2025

Study information

• Verified date: February 2023
• Source: EndoStream Medical
• Contact: Hadas Abalia-Didi
• Phone: +972-50-9064868
• Email: hadas[@]endostream.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Patients with ruptured brain aneurysms will be treated with the Nautilus, then will be followed up for one year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Ruptured Cerebral Aneurysm

Intervention

Device:
• Nautilus Intrasaccular Bridging System
Patients will be treated with the Nautilus, then followed-up for 12 months

Locations

Country	Name	City	State
United States	Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
EndoStream Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	device-related Serious Adverse Event	Proportion of subjects with a device-related Serious Adverse Event	12 months
Secondary	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
Secondary	Distribution of parent vessel compromise	The percentage of parent vessel compromise will be evaluated by treating physician	12 months
Secondary	Coil/Device entanglement	Proportion of events of Coil/Nautilus entanglement during implantation which precludes the coil from being removed or adjusted	During procedure
Secondary	Technical Success	Device placement success rate	During procedure