Medical Device for Brain Aneurysm

(TORNADO-US Trial)

Recruiting at 4 trial locations

Overseen By Hadas Abalia-Didi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: EndoStream Medical

Disqualifiers: Neurological deficit, Cardiovascular disease, Organ failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During procedure

45 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known allergy to Nickel and/or Heparin that cannot be medically treated, you may not be eligible to participate.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the idea that Medical Device for Brain Aneurysm (also known as: Nautilus Intrasaccular Bridging System, Nautilus Intrasaccular System, Nautilus Intrasaccular Bridging System) is an effective treatment?

The available research shows that the Nautilus Intrasaccular System is effective in treating wide-necked brain aneurysms. In a study involving 41 patients, the device was used successfully to treat intracranial aneurysms. The Nautilus helps by providing a barrier at the aneurysm neck, which supports the placement of coils to block the aneurysm. This method is considered advantageous because it can be used safely without the need for additional medication to prevent blood clots, unlike some other treatments. Additionally, the Nautilus has been shown to completely reconstruct the aneurysm neck, which helps in effectively sealing the aneurysm. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Nautilus Intrasaccular Bridging System for brain aneurysms?

The Nautilus Intrasaccular Bridging System has been shown to help treat complex brain aneurysms by providing a mechanical barrier that supports coil embolization (a procedure to block blood flow to an aneurysm). Studies have demonstrated its successful use in treating wide-necked aneurysms, which are challenging to manage, by improving occlusion rates and reducing complications. ^{1 2 3 4 5}

What safety data exists for the Nautilus device for brain aneurysms?

The Nautilus Intrasaccular Bridging System is a CE-marked device designed for coil embolization of wide-neck cerebral aneurysms. Initial safety data comes from a single-center case series involving 41 patients, indicating its use in treating intracranial aneurysms. The device is noted for its intrasaccular nature, which allows it to be used safely in both unruptured and ruptured aneurysms without the need for dual antiplatelet therapy. It is fully resheathable and radiopaque, and its design facilitates complete neck reconstruction, which is advantageous over other intrasaccular and intraluminal flow diversion options. However, long-term safety and efficacy data are still being accumulated. ^{1 2 4 6 7}

Is the Nautilus Intrasaccular System safe for treating brain aneurysms?

The Nautilus Intrasaccular System is considered safe for treating both unruptured and ruptured brain aneurysms, as it does not require additional medication to prevent blood clots and has been successfully used in various cases without reported safety concerns. ^{1 2 4 6 7}

Is the Nautilus Intrasaccular Bridging System a promising treatment for brain aneurysms?

Yes, the Nautilus Intrasaccular Bridging System is a promising treatment for brain aneurysms. It helps in treating complex aneurysms by providing a strong support at the aneurysm's neck, which makes it easier to use coils to block the aneurysm. This system is designed to be safe and effective, even in difficult cases, and has been successfully used in various patients. ^{1 2 4 5 8}

How is the Nautilus Intrasaccular Bridging System treatment different from other treatments for brain aneurysms?

The Nautilus Intrasaccular Bridging System is unique because it provides a mechanical barrier at the neck of a brain aneurysm to support coil embolization, without needing dual antiplatelet therapy, which is often required with other treatments. Its 'tornado-like' shape allows for complete neck reconstruction, making it suitable for both unruptured and ruptured aneurysms. ^{1 2 4 5 8}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

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

Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.

You have a bulge in a blood vessel that is 5 millimeters or larger.

Exclusion Criteria

You have a pre-existing condition that significantly affects your ability to function independently.

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

I have another aneurysm that might need treatment within a year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients with ruptured brain aneurysms are treated with the Nautilus device

During procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Nautilus Intrasaccular Bridging System

Trial Overview 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.

Participant Groups

Group I: Patients treated with the device Experimental Treatment 1 Intervention

Nautilus Intrasaccular Bridging System is already approved in European Union for the following indications:

Approved in European Union as Nautilus Intrasaccular System for:

• Wide-necked intracranial aneurysms

Who Is Running the Clinical Trial?

EndoStream Medical

Lead Sponsor

Trials

2

Recruited

80+

Findings from Research

The Nautilus device is a new intrasaccular bridging tool designed to improve the treatment of wide-necked cerebral aneurysms, enhancing occlusion rates while reducing recurrence and complications.

This CE-marked device is flexible, nitinol-based, and can be delivered through a standard microcatheter, making it a practical option for clinicians dealing with complex aneurysms, as demonstrated in a case of an anterior communicating artery aneurysm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nautilus-assisted coil embolization for a complex AcomA wide-necked aneurysm in the setting of acute subarachnoid hemorrhage. Sirakov, A., Matanov, S., Bhogal, P., et al.[2022]

The Nautilus Intrasaccular System was used to treat 41 patients with intracranial aneurysms, achieving immediate Class I occlusion in 73.1% of cases, indicating effective treatment outcomes.

The procedure demonstrated good safety, with no technical complications and a low rate of serious adverse events, as 94.5% of patients had favorable outcomes at follow-up, including no procedural-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment of wide-necked intracranial aneurysms using the Nautilus Intrasaccular System: initial case series of 41 patients at a single center. Sirakov, A., Bhogal, P., Sirakova, K., et al.[2023]

The Contour Neurovascular System was successfully implanted in 90% of the 60 intracranial aneurysms treated, showing significant improvement in occlusion rates over time, reaching 89.3% at 1 year.

The device demonstrated a good safety profile with only 3.3% technical complications and no permanent morbidity or mortality, indicating it is a safe option for treating intracranial aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endosaccular flow disruption with the Contour Neurovascular System: angiographic and clinical results in a single-center study of 60 unruptured intracranial aneurysms. Biondi, A., Primikiris, P., Vitale, G., et al.[2023]

The Nautilus device is a new intrasaccular bridging implant designed for the safe and effective treatment of wide-neck cerebral aneurysms, allowing for complete neck reconstruction during coil embolization without the need for dual antiplatelet therapy.

This device has been granted a CE mark in the European Union and is compatible with standard microcatheters, making it a versatile option for both unruptured and ruptured aneurysms, potentially improving patient safety and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nautilus-Assisted Coiling of an Unruptured Wide-Necked Aneurysm of the Posterior Communicating Artery. Matanov, S., Sirakov, A., Sirakova, K., et al.[2021]

The novel aneurysm intrasaccular occlusion device (AIOD) demonstrated complete occlusion of sidewall aneurysms immediately after implantation in swine, indicating its potential effectiveness for acute treatment.

In longer-term studies with canines, the AIOD maintained high occlusion rates (71.3% to 100%) at 6 and 12 weeks, with histological analysis showing healthy tissue formation at the aneurysm neck and no significant inflammation, suggesting good safety and healing properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary in vivo evaluation of a novel intrasaccular cerebral aneurysm occlusion device. Moftakhar, R., Xu, F., Aagaard-Kienitz, B., et al.[2016]

The SEAL™ device was successfully used to treat a complex, ruptured wide-necked aneurysm in a patient with acute subarachnoid hemorrhage, demonstrating its feasibility and safety during deployment.

One year after treatment, the aneurysm remained completely occluded with no safety issues, indicating the SEAL™ device's potential for long-term effectiveness in challenging aneurysm cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of a ruptured shallow trilobed cerebral aneurysm with the novel saccular endovascular aneurysm lattice (SEAL) device: A case report with one year follow-up. Pabon, B., Torres, V., Woodward, K., et al.[2023]

In a review of 1217 patients with brain aneurysms treated using intrasaccular flow disruption (IFD), the treatment demonstrated a low complication rate, with hemorrhage occurring in only 1.2% of cases and a permanent neurological deficit in 1.0%.

However, complete occlusion of the aneurysms was achieved in only 50.1% of cases at 12 months, indicating that while IFD is safe, its efficacy in fully closing aneurysms may need improvement and further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrasaccular flow disruption for brain aneurysms: a systematic review of long-term outcomes. Chen, CJ., Dabhi, N., Snyder, MH., et al.[2022]

Intrasaccular flow diverters, particularly the Woven EndoBridge (WEB) device, have become important tools for treating complex wide-necked intracranial aneurysms, with the WEB being the only device approved by the FDA in the U.S.

Several other intrasaccular devices, such as the Luna/Artisse and Medina Embolic Systems, have received CE mark approval in Europe, indicating their safety and efficacy in clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mini-review of intrasaccular flow diverters. Hecker, C., Broussalis, E., Griessenauer, CJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Nautilus-assisted coil embolization for a complex AcomA wide-necked aneurysm in the setting of acute subarachnoid hemorrhage. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Endovascular treatment of wide-necked intracranial aneurysms using the Nautilus Intrasaccular System: initial case series of 41 patients at a single center. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Endosaccular flow disruption with the Contour Neurovascular System: angiographic and clinical results in a single-center study of 60 unruptured intracranial aneurysms. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Nautilus-Assisted Coiling of an Unruptured Wide-Necked Aneurysm of the Posterior Communicating Artery. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Preliminary in vivo evaluation of a novel intrasaccular cerebral aneurysm occlusion device. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment of a ruptured shallow trilobed cerebral aneurysm with the novel saccular endovascular aneurysm lattice (SEAL) device: A case report with one year follow-up. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Intrasaccular flow disruption for brain aneurysms: a systematic review of long-term outcomes. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A mini-review of intrasaccular flow diverters. [2022]