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

Primary Purpose

Ruptured Cerebral Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nautilus Intrasaccular Bridging System
Sponsored by
EndoStream Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ruptured Cerebral Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Subject is currently participating in another interventional clinical study. Subject with a relative contraindication to angiography (i.e., allergy to contrast media, coagulopathy, etc.)

Sites / Locations

  • Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients treated with the device

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2022
Last Updated
February 15, 2023
Sponsor
EndoStream Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05550571
Brief Title
A Medical Device to Treat Wide-Neck Brain Aneurysms
Acronym
TORNADO-US
Official Title
Treatment of Ruptured Wide-Neck Aneurysms With Nautilus Device Assisted Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoStream Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ruptured Cerebral Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients treated with the device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Nautilus Intrasaccular Bridging System
Intervention Description
Patients will be treated with the Nautilus, then followed-up for 12 months
Primary Outcome Measure Information:
Title
The proportion of subjects experiencing death or stroke
Description
The proportion of subjects experiencing death or stroke in treated vascular territory measured using the NIH stroke scale
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The proportion of subjects with complete aneurysm occlusion
Description
The proportion of subjects with complete aneurysm occlusion (defined as Raymond Roy scale =1) without retreatment at 1-year follow-up imaging
Time Frame
12 months
Title
device-related Serious Adverse Event
Description
Proportion of subjects with a device-related Serious Adverse Event
Time Frame
12 months
Title
aneurysm occlusion at the conclusion of the treatment procedure
Description
Proportion of subjects with aneurysm occlusion at the conclusion of the treatment procedure (assessed via the Raymond Roy scale)
Time Frame
During procedure
Title
Distribution of parent vessel compromise
Description
The percentage of parent vessel compromise will be evaluated by treating physician
Time Frame
12 months
Title
Coil/Device entanglement
Description
Proportion of events of Coil/Nautilus entanglement during implantation which precludes the coil from being removed or adjusted
Time Frame
During procedure
Title
Technical Success
Description
Device placement success rate
Time Frame
During procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Subject is currently participating in another interventional clinical study. Subject with a relative contraindication to angiography (i.e., allergy to contrast media, coagulopathy, etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Abalia-Didi
Phone
+972-50-9064868
Email
hadas@endostream.com
Facility Information:
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sukaina Davdani
Phone
516-407-0256
Email
sukaina.davdani@mountsinai.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Medical Device to Treat Wide-Neck Brain Aneurysms

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