Medical Device for Brain Aneurysm

(TORNADO-US Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medical device called the Nautilus Intrasaccular Bridging System to determine its safety and effectiveness in treating wide-neck ruptured brain aneurysms. A brain aneurysm is a bulge in a blood vessel in the brain, and this device aims to repair it. The trial seeks individuals with a confirmed wide-neck ruptured aneurysm who are in stable condition. Eligible participants must not have experienced recent major neurological issues, such as a stroke or head trauma. The goal is to assess whether this device can become a reliable treatment option for this condition. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that this medical device is safe for treating wide-neck ruptured brain aneurysms?

Research has shown that the Nautilus Intrasaccular Bridging System is generally safe for treating brain aneurysms. Studies have found that this device works well without requiring additional medication, simplifying treatment for patients. For instance, one study found that using the Nautilus device for wide-neck aneurysms was both safe and effective. Another study showed positive safety results when the device was used for both ruptured and unruptured aneurysms. Overall, the Nautilus device is considered a safe choice for managing complex brain aneurysms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Nautilus Intrasaccular Bridging System is unique because it offers a new way to treat brain aneurysms by physically bridging the aneurysm from inside, potentially reducing the risk of rupture. Unlike traditional treatments like surgical clipping or endovascular coiling, this device is designed to be less invasive and may offer quicker recovery times for patients. Researchers are excited because it could provide a safer, more efficient option for those at risk of aneurysm complications, possibly improving outcomes and quality of life.

What evidence suggests that the Nautilus Intrasaccular Bridging System is effective for treating brain aneurysms?

Research has shown that the Nautilus Intrasaccular Bridging System, which participants in this trial will receive, works well for treating wide-neck brain aneurysms. One study found it to be a safe and effective method for blocking blood flow to an aneurysm. Another study confirmed its safety and effectiveness for both burst and unburst aneurysms. An initial series of cases with 41 patients also supported its effectiveness for these aneurysms. These findings suggest that the device could be helpful for treating wide-neck burst brain aneurysms. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

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]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/SVIN.122.000770

Four‐Year Follow‐Up on the First‐in‐Human Experience ... The Nautilus appears to add a simple, safe, and effective option and solution to the coil embolization of the wide‐neck aneurysm.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9706270/

A technical note on Nautilus-assisted coiling of wide-necked ... We retrospectively reviewed eight consecutive patients who underwent treatment for intracranial aneurysms with the Nautilus intrasaccular bridging system ...

3. jnis.bmj.com jnis.bmj.com/content/15/10/989

Endovascular treatment of wide-necked intracranial ... This study demonstrates good safety and effectiveness using the Nautilus Intrasaccular System to treat both ruptured and unruptured intracranial aneurysms.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05550571

A Medical Device to Treat Wide-Neck Brain Aneurysms The study aims to evaluate the safety and probable benefit of a medical device to treat wide-neck ruptured brain aneurysms.

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1552848/full

Intrasaccular therapy in wide-neck intracranial aneurysms Endovascular treatment of wide-necked intracranial aneurysms using the Nautilus Intrasaccular system: initial case series of 41 patients at a single center.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35818746/

Intrasaccular neck-bridging: A technical note on Nautilus ... Conclusion: Nautilus-assisted coil embolization represents a rapid and safe solution for complex cerebral aneurysms. In our opinion this device ...

7. withpower.com withpower.com/trial/phase-8e771

Medical Device for Brain Aneurysm (TORNADO-US Trial) The Nautilus Intrasaccular System is considered safe for treating both unruptured and ruptured brain aneurysms, as it does not require additional medication to ...