SEAL™ System for Brain Aneurysms

(SEAL™IT Trial)

Recruiting at 5 trial locations

Overseen By Alyssa Axe, MBA, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Galaxy Therapeutics INC

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, CNS vasculitis, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

Duration: Immediate post-procedure

279 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called the SEAL™ system for brain aneurysms. The primary goal is to assess the safety and effectiveness of this device for treating unruptured and certain types of ruptured brain aneurysms (bulging blood vessels in the brain). Suitable candidates for this trial have a specific type of aneurysm that hasn't burst yet or has recently burst but are currently stable and without severe symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Do I have to stop taking my current medications for the SEAL™ System trial?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulation therapy, you may not be eligible to participate.

What prior data suggests that the SEAL™ Saccular Endovascular Aneurysm Lattice system is safe for treating saccular intracranial aneurysms?

Research has shown that the SEAL™ Saccular Endovascular Aneurysm Lattice system is generally safe. In one study, researchers treated 33 aneurysms in 29 patients and assessed safety at 24 hours and three months post-treatment. Patients tolerated the treatment well, with no major safety concerns during this period.

Another study described the system as a "third way" to treat brain aneurysms and reported positive safety results after one year. The device performed effectively and did not cause major problems during the treatment period.

These findings suggest the SEAL™ system is generally safe for patients. The studies indicate that patients handled the treatment well, with few serious issues reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain aneurysms, which often involve surgical clipping or endovascular coiling, the SEAL™ Saccular Endovascular Aneurysm Lattice System introduces an innovative approach by using a lattice structure to stabilize the aneurysm from within. This unique method aims to provide a more secure and durable repair, potentially reducing the risk of recurrence. Researchers are excited about this treatment because it could offer a less invasive and more effective option for patients, improving outcomes and recovery times.

What evidence suggests that the SEAL™ System is effective for treating brain aneurysms?

Research has shown that the SEAL™ Saccular Endovascular Aneurysm Lattice system, the focus of this trial, holds promise for treating brain aneurysms. Patients have experienced positive results, achieving successful aneurysm closure at both 24 hours and 6 months post-treatment. Studies highlight the device's ability to treat challenging aneurysms, including those with unusual shapes. Importantly, early findings have shown the SEAL device to be safe, with no major concerns reported. Overall, the evidence supports the potential effectiveness of the SEAL system for managing brain aneurysms. ^{1 2 3 6 7}

Who Is on the Research Team?

David J Altschul, MD

Principal Investigator

Montefiore Health System

Brian Jankowitz, MD

Principal Investigator

JFK University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with stable brain aneurysms, either ruptured without severe neurological issues or unruptured but needing treatment. Candidates must fit specific criteria including a Hunt and Hess scale of 3 or less, no seizures at SAH onset, and suitability for the SEAL device according to AHA guidelines.

Inclusion Criteria

Meet the AHA guidelines for management of ruptured aneurysm.6

I was mostly independent in daily activities before my aneurysm.

My brain hemorrhage severity is low to moderate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated using the SEAL™ System for saccular intracranial aneurysms

Immediate post-procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at 24 hours or discharge, 3 months, 6 months, and 12 months

Long-term follow-up

Annual follow-up for a total of five years post-procedure

5 years

What Are the Treatments Tested in This Trial?

Interventions

• SEAL™ Saccular Endovascular Aneurysm Lattice system

Trial Overview The SEAL™ Saccular Endovascular Aneurysm Lattice System is being tested for its safety and effectiveness in treating saccular intracranial aneurysms. The results will support a premarket approval submission.

How Is the Trial Designed?

Group I: Single arm (The SEAL™ Saccular Endovascular Aneurysm Lattice System) Experimental Treatment 1 Intervention

Prospective, US and OUS single-arm, multicenter, interventional study.

SEAL™ Saccular Endovascular Aneurysm Lattice system is already approved in United States, European Union for the following indications:

Approved in United States as SEAL Device for:

• Saccular intracranial aneurysms

Approved in European Union as SEAL System for:

• Saccular intracranial aneurysms

Who Is Running the Clinical Trial?

Galaxy Therapeutics INC

Lead Sponsor

Trials

3

Recruited

510+

Published Research Related to This Trial

The Nellix endovascular aneurysm sealing system offers a promising alternative to traditional methods for treating aortic aneurysms, utilizing a unique design that may reduce the risk of device-related failures like endoleaks.

While initial efficacy data is encouraging, there are reported complications such as Type 1 and 2 endoleaks and graft stenosis, highlighting the need for further understanding and management of these adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary interventions after endovascular aneurysm sac sealing: endoleak embolization and limb-related interventions. Ameli-Renani, S., Morgan, RA.[2017]

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 study of 28 patients undergoing Nellix aneurysm repair, the manual 'segmental cylinder' method for predicting polymer volume was found to be more accurate than the 3D software method, with no significant difference from the actual volume used.

While the manual method slightly underestimated the polymer volume by 2.8%, the 3D method overestimated it by 7.0%, indicating that although 3D predictions are faster, they may lead to planning inaccuracies that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Manual and Three-Dimensional Modalities in Predicting Nellix Polymer Volume. Elbasty, A., Mughal, N., Delbridge, M.[2022]

The Nellix® system for endovascular aneurysm repair (EVAR) has shown a high technical success rate of 94% in a multicenter registry, with no severe adverse events like migration or occlusion reported.

This innovative method uses a polymer filling to completely seal the aneurysm, which may reduce the risk of endoleaks and the need for secondary interventions, indicating promising long-term durability based on 4 years of sheep studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nellix® endovascular aneurysm sealing (EVAS) - a new technology for endovascular management of infrarenal aortic aneurysms]. Böckler, D., Peters, AS., Pfeiffer, S., et al.[2014]

The Nellix endovascular aneurysm sealing system is a new type of aortic stent designed to improve upon traditional endovascular aneurysm repair methods.

In a case study of a 65-year-old male, a misdiagnosis of acute aortic dissection occurred 7 days after Nellix stent insertion, emphasizing the need for awareness of the stent's unique radiological appearances to avoid diagnostic errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Misdiagnosis of abdominal aortic dissection: image findings with the Nellix endovascular aneurysm sealing system. de Souza, PJ., Rodway, A., Pankhania, A.[2020]

The Nellix™ EndoVascular Aneurysm Sealing system represents a new approach to treating aortic aneurysms by sealing the aneurysm sac with polymer-filled endobags, which may reduce complications like stent migration and endoleaks compared to traditional methods.

Current studies are investigating the clinical effectiveness of this system, focusing on its ability to lower complication rates and the need for additional interventions compared to conventional endovascular repair techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal Aortic Aneurysm Repair Using Nellix™ EndoVascular Aneurysm Sealing. van den Ham, LH., Zeebregts, CJ., de Vries, JP., et al.[2015]

The study of 46 patients undergoing the Nellix EndoVascular Aneurysm Sealing (EVAS) system revealed that accurate positioning in the aortic neck is challenging, with about 50% of the potential seal being missed, which could contribute to higher complication rates.

The methodology used to assess the nonapposition surface (NAS) showed high reliability (ICC 0.897), indicating that this approach can effectively evaluate the positioning of the endograft and inform preoperative planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apposition and Positioning of the Nellix EndoVascular Aneurysm Sealing System in the Infrarenal Aortic Neck. van Noort, K., Overeem, SP., van Veen, R., et al.[2019]

The Nellix endovascular aneurysm sealing system offers a promising alternative to traditional methods for treating aortic aneurysms, utilizing a unique design that may enhance resistance to forces and reduce device-related failures like endoleaks.

While initial efficacy data is encouraging, there are reported complications such as Type I and II endoleaks, graft stenosis, and occlusion, highlighting the need for further understanding and management of these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous interventions following endovascular aneurysm sac sealing: Endoleak embolization and limb-related adverse events. Ameli-Renani, S., Morgan, RA.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05831202

SEAL™IT: Saccular Endovascular Aneurysm Lattice ... To establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms. The ...

2. jnis.bmj.com jnis.bmj.com/content/17/Suppl_2/A10.3

A340 Update on the saccular endovascular aneurysm ... Conclusion The preliminary safety and efficacy of the SEAL™ intrasaccular device is promising; final updates will be presented at the ESMINT. Conflict of ...

3. neuronewsinternational.com neuronewsinternational.com/seal-device-galaxy-therapeutics-brain-2023/

Galaxy SEAL device demonstrates positive one-year ... A device labelled “the third way” to potentially treat intracranial aneurysms via an intrasaccular approach has demonstrated positive effectiveness and safety ...

4. ahajournals.org ahajournals.org/doi/10.1161/SVIN.03.suppl_1.005

5: Interim Results of PRE‐SEAL IT Saccular Endovascular ... The interim results of the PRE SEAL‐IT trial demonstrated promising complete occlusion rates at 24‐hour and 6 month follow‐up with no safety concerns.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10399503/

Treatment of a ruptured shallow trilobed cerebral aneurysm ... The SEAL device is a promising new novel technology which has the potential to treat very shallow aneurysms with limited height and irregular, multilobulated ...

6. jnis.bmj.com jnis.bmj.com/content/15/Suppl_1/A244.1

LB-004 Novel SEAL device feasibility trial: safety & effectiveness Here, we present the final demographic, procedural, 24-hour, and 3-month safety and effectiveness results from the 33 aneurysm that were treated in 29 patients ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05880680?term=AREA%5BConditionSearch%5D(%22Aneurysm,%20Ruptured%22)&rank=1

SEAL™ME: Saccular Endovascular Aneurysm Lattice ... 5 If there is evidence of an additional aneurysm requiring treatment, the secondary aneurysm must also be treatable using a SEAL™ System Device, either during a ...