Ruptured Cerebral AneurysmTORNADO-USNCT05550571
A Medical Device to Treat Wide-Neck Brain Aneurysms
A study testing Nautilus Intrasaccular Bridging System in people with Ruptured Cerebral Aneurysm, run by EndoStream Medical at 5 sites in 2 countries.
Trial summary
The study aims to evaluate the safety and probable benefit of a medical device to treat wide-neck ruptured brain aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ruptured Cerebral Aneurysm
- What is being tested?
- Nautilus Intrasaccular Bridging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 17 Dec 2022to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.)
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
The research Foundation For The State Of New York On Behalf Of The University At Buffalo
Buffalo, New York, 14203
Baptist Health Ambulatory Services, Inc. d/b/a/ Baptist Health Research Institute
Jacksonville, Florida, 32207
Mount Sinai
New York, New York, 10029
University of South Florida
Tampa, Florida, 33620
About this study
Official title: Treatment of Ruptured Wide-Neck Aneurysms With Nautilus Device Assisted Occlusion
The study aims to evaluate the safety and probable benefit of a medical device to treat wide-neck ruptured brain aneurysms.
Read the detailed description
Patients with ruptured brain aneurysms will be treated with the Nautilus, then will be followed up for one year.
- Conditions
- Ruptured Cerebral Aneurysm
- Being tested
- Nautilus Intrasaccular Bridging System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nautilus Intrasaccular Bridging SystemDevice
Patients will be treated with the Nautilus, then followed-up for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with the device | Experimental | Not described Receives: Device: Nautilus Intrasaccular Bridging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (6)
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
Measured: 12 months
device-related Serious Adverse Event
Proportion of subjects with a device-related Serious Adverse Event
Measured: 12 months
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)
Measured: During procedure
Distribution of parent vessel compromise
The percentage of parent vessel compromise will be evaluated by treating physician
Measured: 12 months
Coil/Device entanglement
Proportion of events of Coil/Nautilus entanglement during implantation which precludes the coil from being removed or adjusted
Measured: During procedure
Technical Success
Device placement success rate
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start17 Dec 2022
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured Cerebral AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EndoStream Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550571
- Sponsor's protocol ID
- CLD-329(US)
- Acronym
- TORNADO-US
- Status last verified
- Apr 2025
- First submitted
- 11 Sep 2022
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Ruptured Wide-Neck Aneurysms With Nautilus Device Assisted Occlusion
- ClinicalTrials.gov ID
- NCT05550571
- Acronym / sponsor ID
- TORNADO-US / CLD-329(US)
- Conditions
- Ruptured Cerebral Aneurysm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- EndoStream MedicalIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2022 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with the device | Experimental | Device: Nautilus Intrasaccular Bridging System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nautilus Intrasaccular Bridging SystemPatients will be treated with the Nautilus, then followed-up for 12 months | Device | Patients treated with the device |
Primary outcome
The proportion of subjects experiencing death or stroke
Time frame: 12 months
The proportion of subjects experiencing death or stroke in treated vascular territory measured using the NIH stroke scale
6 secondary outcomes
The proportion of subjects with complete aneurysm occlusion
Time frame: 12 months
device-related Serious Adverse Event
Time frame: 12 months
aneurysm occlusion at the conclusion of the treatment procedure
Time frame: During procedure
Distribution of parent vessel compromise
Time frame: 12 months
Coil/Device entanglement
Time frame: During procedure
Technical Success
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nautilus Intrasaccular Bridging System in people with Ruptured Cerebral Aneurysm, run by EndoStream Medical at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects experiencing death or stroke (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.