What is the mechanism of action of this treatment?

The Flow Diverter is a medical device used to treat wide-neck brain aneurysms by redirecting blood flow away from the aneurysm sac, promoting healing and preventing rupture. It is placed within the parent blood vessel, creating a scaffold that encourages blood to flow along the normal vessel pathway rather than entering the aneurysm. This reduction in blood flow within the aneurysm allows for the formation of a stable clot and eventual vessel wall remodeling, reducing the risk of rupture. This mechanism is crucial for brain aneurysm patients as it addresses the aneurysm's structural weakness, significantly lowering the chances of a potentially life-threatening hemorrhage.

What side effects are associated with this type of intervention?

The most common treatments for brain aneurysms, particularly those involving flow diverters, can have several side effects. These may include headaches, minor bleeding or bruising at the catheter insertion site, and transient neurological symptoms such as dizziness or vision changes. More serious but less common side effects include stroke, vessel occlusion, and device-related complications such as migration or improper placement. It is crucial for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several devices for the treatment of brain aneurysms, particularly those that function as flow diverters. Flow diverters, such as the Pipeline Embolization Device, are designed to redirect blood flow away from the aneurysm sac, promoting healing and preventing rupture. These devices are typically used for wide-neck or complex aneurysms that are not easily treated with traditional coiling methods. Other similar devices include the Surpass Streamline Flow Diverter and the FRED (Flow Re-Direction Endoluminal Device). These treatments have shown promise in reducing the risk of aneurysm rupture and improving patient outcomes.

What other types of research exist?

A promising novel alternative to Flow Diverters for treating brain aneurysms in 2024 is the new medical device currently being evaluated for the treatment of wide-neck ruptured brain aneurysms. This device aims to improve safety and provide probable benefits in managing such aneurysms. Further details on its efficacy and safety profile will likely emerge as more clinical data becomes available.

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Intrasaccular Bridging System

Medical Device for Brain Aneurysm (TORNADO-US Trial)

N/A

Recruiting

Research Sponsored by EndoStream Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is neurologically stable with a Hunt & Hess score of I, II, or III.

Subject is ≥18 years old

Must not have

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.

Women of child-bearing potential age (18-55) who cannot provide a negative pregnancy test.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called Nautilus to treat patients with wide-neck ruptured brain aneurysms. These aneurysms are hard to treat with usual methods. The device helps secure the damaged blood vessel to stop more bleeding and allow healing. The Nautilus Intrasaccular System has been used in initial case series to treat both ruptured and unruptured intracranial aneurysms.

Who is the study for?

This trial is for adults over 18 with a specific type of ruptured brain aneurysm that's wide (4-7mm) and has a dome size of at least 5mm. Participants should be neurologically stable, able to consent, and follow the study schedule. It excludes pregnant women, those with recent neurological issues or serious health conditions, certain pre-existing diseases like Moyamoya disease, allergies to Nickel/Heparin, or involvement in another clinical study.

What is being tested?

The Nautilus Intrasaccular Bridging System is being tested for its safety and potential benefits in treating wide-neck ruptured brain aneurysms. The device aims to stabilize the aneurysm and prevent further bleeding into the brain.

What are the potential side effects?

While not explicitly listed here, side effects may include typical risks associated with medical devices for aneurysms such as reaction to materials used in the device (like Nickel), complications from invasive procedures like bleeding or infection, and any specific reactions related to this new system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain function is stable with a mild to moderate condition.

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I am 18 years old or older.

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I have a recently burst brain aneurysm that is 4-7mm wide.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a stroke, head injury, or brain surgery in the last 6 months.

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I am a woman aged 18-55 and cannot provide a negative pregnancy test.

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I have serious health conditions that could increase my risk in a study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of subjects experiencing death or stroke

Secondary study objectives

Coil/Device entanglement

Distribution of parent vessel compromise

Technical Success

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients treated with the deviceExperimental Treatment1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Flow Diverter is a medical device used to treat wide-neck brain aneurysms by redirecting blood flow away from the aneurysm sac, promoting healing and preventing rupture. It is placed within the parent blood vessel, creating a scaffold that encourages blood to flow along the normal vessel pathway rather than entering the aneurysm. This reduction in blood flow within the aneurysm allows for the formation of a stable clot and eventual vessel wall remodeling, reducing the risk of rupture. This mechanism is crucial for brain aneurysm patients as it addresses the aneurysm's structural weakness, significantly lowering the chances of a potentially life-threatening hemorrhage.