Medical Device for Brain Aneurysm (TORNADO-US Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: EndoStream Medical
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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.
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.
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.12357
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.23478
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.12367
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.
I am 18 years old or older.
I have a recently burst brain aneurysm that is 4-7mm wide.
Exclusion Criteria
I have not had a stroke, head injury, or brain surgery in the last 6 months.
I am a woman aged 18-55 and cannot provide a negative pregnancy test.
I have serious health conditions that could increase my risk in a study.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Patients treated with the deviceExperimental Treatment1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mount SinaiNew York, NY
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Who is running the clinical trial?
EndoStream MedicalLead Sponsor
References
Preliminary in vivo evaluation of a novel intrasaccular cerebral aneurysm occlusion device. [2016]Current endovascular technology does not offer a perfect solution for all cerebral aneurysms. Our group has built two versions of a novel aneurysm intrasaccular occlusion device (AIOD) to address the drawbacks associated with current occlusion devices. The objective of the present study was to perform pilot proof of concept in vivo testing of this new AIOD in swine and canines.
Nautilus-Assisted Coiling of an Unruptured Wide-Necked Aneurysm of the Posterior Communicating Artery. [2021]A variety of recently introduced devices have allowed more complex aneurysms to be rendered for endovascular embolization. Tiny and sophisticated implants are nowadays designed to provide further either temporary or permanent remodeling of the wide-necked aneurysms and improve coil occlusion rates.1-4 Such improvements in the technical armamentarium include the Woven EndoBridge (Sequent Medical, California, USA), the Medina Embolic Device (Medtronic, Irvine, California, USA), The Contour Neurovascular System (Cerus Endovascular, Fremont, California, USA), and pCONUS 2 HPC (Phenox, GmbH, Bohum, Germany).5-7 Intrasaccular neck bridging is a conceptually new technique descending from the theoretical combination of intrasaccular flow diversion and temporary-stent assisted coiling.8 The Nautilus (EndoStream Medical, Tel Aviv, Israel) is an intrasaccular bridging device that offers complete neck reconstruction in coil embolization of wide-neck cerebral aneurysms. It has been granted a CE mark by the European Union. The detachable intrasaccular implant comprises flexible and "tornado-like"-shaped Nitinol-based layers. The device is compatible with a standard microcatheter with minimal 0.0165″ inner diameter and is fully radiopaque and fully resheathable. The device's intrasaccular nature and the fact that it does not harbor any intraluminal satellite parts suggest that the implant can be safely used in both unruptured and ruptured case scenarios without the need for dual antiplatelet therapy. This is what we consider a great advantage of the proposed technique over the alternative options of intrasaccular and intraluminal flow diversion. This technical video (Video 1) demonstrates the successful obliteration of a complex posterior communicating artery aneurysm with Nautilus-assisted endovascular coiling. To our knowledge, this is the first technical video demonstrating an in-vivo and step-by-step implementation of this novel device.
Nautilus-assisted coil embolization for a complex AcomA wide-necked aneurysm in the setting of acute subarachnoid hemorrhage. [2022]Numerous devices and sophisticated strategies have been developed to further increase the number of aneurysms amenable to endovascular treatment.1-4 Despite the superfluity of available neurovascular armamentarium, wide-necked bifurcation aneurysms can still pose a significant technical challenge to the treating clinician.5-7 Neck bridging is a conceptually new approach, which provides increased occlusion rates with lower recurrence and complications rates.8-10 The Nautilus (EndoStream Medical) is an intrasaccular bridging device intended to assist in coil embolization of wide-necked cerebral aneurysms. This CE-marked device, available in various sizes, consists of flexible-layers, and is a nitinol-based, detachable implant. The device is delivered through a standard microcatheter with a minimal 0.0165" inner diameter and is fully radiopaque and completely resheathable.Owing to its unique 'tornado' like shape the device entirely reconstructs the aneurysmal neck, which facilitates the following coil embolization. In this video 1, we demonstrate the use of Nautilus - assisted coil embolization for a complex anterior communicating artery (AcomA) wide-necked aneurysm in the setting of acute subarachnoid hemorrhage. neurintsurg;14/3/310/V1F1V1Video 1.
Intrasaccular flow disruption for brain aneurysms: a systematic review of long-term outcomes. [2022]The long-term safety and efficacy of intrasaccular flow disruption (IFD) for the treatment of brain aneurysms remain unclear. With accumulating experience and increasing use of IFD devices, recent studies have provided additional data regarding their outcomes. This review summarizes the long-term outcomes of IFD-treated brain aneurysms.
A mini-review of intrasaccular flow diverters. [2022]Treatment of wide-necked complex intracranial aneurysms continues to challenge neurointerventionalists. Intrasaccular flow diverters have expanded the armamentarium considerably and are now used extensively. While five types of devices have already obtained the CE mark for use within Europe, only the Woven EndoBridge (WEB) device is approved by the US Food and Drug Administration. Other intrasaccular devices are the Luna/Artisse Aneurysm Embolization System (Medtronic), the Medina Embolic Device (Medtronic), the Contour Neurovascular System (Cerus), and the Neqstent Coil Assisted Flow Diverter (Cerus). This mini review will provide a compact overview of these devices and a summary of the current literature.
Endosaccular flow disruption with the Contour Neurovascular System: angiographic and clinical results in a single-center study of 60 unruptured intracranial aneurysms. [2023]The Contour Neurovascular System is a novel device designed to treat intracranial aneurysms by intrasaccular flow disruption. We report our experience and mid-term follow-up in a series of patients treated with the Contour.
Endovascular treatment of wide-necked intracranial aneurysms using the Nautilus Intrasaccular System: initial case series of 41 patients at a single center. [2023]Endovascular treatment of intracranial wide-necked and bifurcation aneurysms (WNBA) is technically challenging. The Nautilus Intrasaccular System is designed to provide a mechanical barrier at the aneurysm neck to support coil embolization. We report the results of a single-center series of patients treated for intracranial aneurysms with the Nautilus.
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]Intrasaccular flow disruption is a viable alternative to other endovascular treatments for saccular or wide-necked bifurcation intracranial aneurysms; however, wide neck aneurysms with irregular shapes or shallow depth may not be amenable to treatment currently available intrasaccular devices. Here, we present the first ever case report of the novel Saccular Endovascular Aneurysm Lattice Embolization System (SEAL™). The versatile utility of the SEAL™ device is demonstrated in a patient with acute subarachnoid hemorrhage (SAH) from a ruptured, complex, left middle cerebral artery (MCA) trilobed shallow wide-necked bifurcation aneurysm. Deployment and implantation of the SEAL device were technically feasible, safe, and conformed well to the irregular shape of the complex, ruptured aneurysm. Immediate total aneurysm occlusion was observed after implantation. Importantly, 1-year angiographic follow-up demonstrated durable, complete occlusion with no safety concerns. The SEAL device is a promising new novel technology which has the potential to treat very shallow aneurysms with limited height and irregular, multilobulated aneurysms.