A Medical Device to Treat Wide-Neck Brain Aneurysms (TORNADO-US)

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

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

Study Overview

• Status: Recruiting
• Conditions: Ruptured Cerebral Aneurysm
• Intervention / Treatment: Device: Nautilus Intrasaccular Bridging System

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadas Abalia-Didi; Phone Number: +972-50-9064868; Email: hadas@endostream.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai
      • Contact: Sukaina Davdani; Phone Number: 516-407-0256; Email: sukaina.davdani@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients treated with the device	Device: Nautilus Intrasaccular Bridging System; Patients will be treated with the Nautilus, then followed-up for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: EndoStream Medical

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: September 11, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CLD-329(US)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No