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

Trial Summary

What is the purpose of this trial?

To establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms. The data from this study will be used to support a premarket approval (PMA) submission.

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 data supports the effectiveness of the SEAL™ System treatment for brain aneurysms?

A case report showed that the SEAL™ device was successfully used to treat a complex brain aneurysm, achieving complete closure of the aneurysm immediately after the procedure and maintaining this result for a year without any safety issues. This suggests the SEAL™ device could be effective for treating certain types of brain aneurysms. ^{1 2 3 4 5}

Is the SEAL™ System for Brain Aneurysms safe for humans?

The SEAL™ System for Brain Aneurysms has been used safely in a case where it was implanted in a patient with a complex brain aneurysm. One year after the procedure, there were no safety concerns reported. ^{1 3 4 6 7}

How is the SEAL™ System treatment for brain aneurysms different from other treatments?

The SEAL™ System is unique because it uses a lattice device to conform to the irregular shape of complex brain aneurysms, providing immediate and complete occlusion, especially for shallow and multilobulated aneurysms that are difficult to treat with existing devices. ^{1 2 3 4 8}

Research Team

David J Altschul, MD

Principal Investigator

Montefiore Health System

Brian Jankowitz, MD

Principal Investigator

JFK University Medical Center

Eligibility Criteria

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

I was mostly independent in daily activities before my aneurysm.

Meet the AHA guidelines for management of ruptured aneurysm.6

I have had a ruptured aneurysm.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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® 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 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]

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]

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]

References

1. 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]

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

Abdominal Aortic Aneurysm Repair Using Nellix™ EndoVascular Aneurysm Sealing. [2015]

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

Misdiagnosis of abdominal aortic dissection: image findings with the Nellix endovascular aneurysm sealing system. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

[Nellix® endovascular aneurysm sealing (EVAS) - a new technology for endovascular management of infrarenal aortic aneurysms]. [2014]

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

Apposition and Positioning of the Nellix EndoVascular Aneurysm Sealing System in the Infrarenal Aortic Neck. [2019]

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

Percutaneous interventions following endovascular aneurysm sac sealing: Endoleak embolization and limb-related adverse events. [2017]

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

Secondary interventions after endovascular aneurysm sac sealing: endoleak embolization and limb-related interventions. [2017]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

A Comparison of Manual and Three-Dimensional Modalities in Predicting Nellix Polymer Volume. [2022]