FRED™ X™ Device for Brain Aneurysm

Recruiting at 25 trial locations

Overseen By Amy Bowles

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Microvention-Terumo, Inc.

Must not be taking: Anticoagulants, Antiplatelets, Thrombolytics, others

Disqualifiers: Intracranial hemorrhage, Cardiac embolism, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

154 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a bleeding disorder or cannot tolerate anticoagulants (blood thinners) or antiplatelet agents, you may be excluded from the study.

What data supports the effectiveness of the FRED X treatment for brain aneurysms?

Research shows that the FRED X device, a new version of the FRED, is designed to improve blood flow in brain aneurysms and enhance healing. Early studies indicate it is safe and effective in treating these aneurysms, with improvements in reducing blood clots and promoting vessel healing. ^{1 2 3 4 5}

What safety data exists for the FRED X device for brain aneurysms?

The FRED X device, used for treating brain aneurysms, has been evaluated for safety in several studies. These studies generally show that the device is safe for use, with some reports of complications, but overall it is considered a feasible and safe option for treating intracranial aneurysms. ^{1 3 5 6 7}

What makes the FRED X treatment unique for brain aneurysms?

The FRED X treatment is unique because it uses a new-generation flow diversion stent designed to reduce the risk of blood clots and improve healing of the blood vessel, offering a novel approach compared to traditional methods for treating brain aneurysms. ^{1 2 3 5 8}

Eligibility Criteria

This trial is for adults with a wide-necked brain aneurysm located in the internal carotid artery, who are not pregnant or breastfeeding, can undergo imaging without allergic reactions, and have no major heart issues or bleeding disorders. Participants must be able to attend follow-up visits for up to 5 years and sign consent forms.

Inclusion Criteria

I can commit to returning for follow-up visits up to 5 years.

Female participants must have a negative pregnancy test if they have had their period in the last 18 months.

I can carry out all my usual duties with no more than slight disability.

Exclusion Criteria

You have a known allergy to contrast dye or a condition that prevents getting imaging tests.

Subject is enrolled in another device or drug study in which participation could confound study results.

I have a narrowed artery near my brain aneurysm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FRED™ X™ device and are monitored for initial safety and effectiveness

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of aneurysm occlusion and parent artery stenosis

12 months

Multiple visits (in-person)

Treatment Details

Interventions

• FRED™ X™

Trial Overview The FRED™ X™ device is being tested in this study. It's designed to treat brain aneurysms by redirecting blood flow. The performance of FRED™ X™ will be compared with the original FRED™ device based on previously established goals from the pivotal study of the latter.

Participant Groups

Group I: Flow Re-Direction Endoluminal Device X Experimental Treatment 1 Intervention

FRED™ X™ device

FRED™ X™ is already approved in United States, European Union for the following indications:

Approved in United States as FRED X for:

• Wide-necked saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm

Approved in European Union as FRED for:

• Intracranial aneurysms

Who Is Running the Clinical Trial?

Microvention-Terumo, Inc.

Lead Sponsor

Trials

32

Recruited

7,000+

Findings from Research

The Flow Re-direction Endoluminal Device (FRED) was successfully deployed in 92.1% of cases for treating cerebral aneurysms, indicating its efficacy in this application.

However, caution is advised when using the FRED in patients with an S-shaped parent vessel or when the device is oversized by more than 2 mm, as these factors were linked to deployment failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Flow Re-direction Endoluminal Device for cerebral aneurysms and causes of failed deployment. Suyama, K., Nakahara, I., Matsumoto, S., et al.[2022]

The Flow Re-direction Endoluminal Device (FRED) demonstrated high efficacy in treating cerebral aneurysms, with 84.6% achieving complete or near-complete occlusion after treatment, particularly effective in smaller and single aneurysms.

The treatment was generally safe, with only 6.5% experiencing major complications, of which only one was clinically relevant, indicating that FRED meets safety standards for intracranial aneurysm treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the dual-layer flow-diverting stent (FRED) for the treatment of intracranial aneurysms. Guimaraens, L., Vivas, E., Saldaña, J., et al.[2020]

The FRED X flow diversion device was successfully used in 44 patients with 45 intracranial aneurysms, demonstrating technical feasibility with 100% successful stent placements and promising early safety outcomes, as only 4 patients experienced symptomatic complications.

At 6 months post-treatment, 89% of the aneurysms showed adequate occlusion, indicating effective treatment, while all patients maintained excellent functional outcomes with a modified Rankin Scale score of 0.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First United States multicenter experience with the new-generation FRED X surface-modified flow diversion stent: feasibility, safety, and short-term efficacy. Abbas, R., Lan, M., Naamani, KE., et al.[2023]

In a study involving 61 patients treated with the FRED flow diverter for intracranial aneurysms, 74.2% achieved complete occlusion of their aneurysms after a median follow-up of 6.3 months, indicating effective treatment outcomes.

The FRED device demonstrated a low complication rate, with only 2.8% experiencing permanent ischemic complications and no procedural mortality, suggesting it is a safe option for patients with intracranial aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pennsylvania Postmarket Multicenter Experience With Flow Redirection Endoluminal Device. Salem, MM., Kvint, S., Hendrix, P., et al.[2023]

In a study involving 20 patients with 24 cerebral aneurysms treated with the Flow Re-Direction Endoluminal Device (FRED), a high complete occlusion rate of 83% was achieved, indicating its efficacy in treating unruptured cerebral aneurysms.

The treatment was found to be safe, with only 4% experiencing intraprocedural complications and no neurological deficits or serious adverse events like aneurysm rupture or hemorrhage reported during follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of flow re-direction endoluminal device (FRED) in the treatment of cerebral aneurysms: a single center experience. Briganti, F., Leone, G., Ugga, L., et al.[2019]

The FRED device demonstrated an excellent safety profile in treating intracranial aneurysms, with low 1-year morbidity and mortality rates of 2.9% and 1.9%, respectively, in a study involving 103 patients.

Efficacy results showed that 73.3% of patients achieved complete occlusion of their aneurysms at 1 year, indicating that the FRED device is effective for this type of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results. Pierot, L., Spelle, L., Berge, J., et al.[2020]

In a study involving 145 patients with challenging intracranial aneurysms, the Flow Redirection Endoluminal Device (FRED) demonstrated a safety profile with only 6.2% experiencing major complications, well below the performance goal of 15%.

The FRED device also showed effectiveness, achieving complete occlusion in 57.6% of cases, surpassing the effectiveness benchmark of 46%, indicating it is a viable treatment option for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial. McDougall, CG., Diaz, O., Boulos, A., et al.[2022]

The Flow-Redirection Endoluminal Device (FRED) was successfully deployed in all 50 patients treated for various types of cerebral aneurysms, with no device-related complications reported, indicating a high safety profile.

At 6 months post-treatment, the FRED demonstrated a high occlusion rate of 87.2%, with complete occlusion in 72.3% of patients at 3 months, suggesting its efficacy in effectively treating cerebral aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FRED Flow Diverter: A Study on Safety and Efficacy in a Consecutive Group of 50 Patients. Luecking, H., Engelhorn, T., Lang, S., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of the Flow Re-direction Endoluminal Device for cerebral aneurysms and causes of failed deployment. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the dual-layer flow-diverting stent (FRED) for the treatment of intracranial aneurysms. [2020]

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

First United States multicenter experience with the new-generation FRED X surface-modified flow diversion stent: feasibility, safety, and short-term efficacy. [2023]

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

The Pennsylvania Postmarket Multicenter Experience With Flow Redirection Endoluminal Device. [2023]

5. Austria pubmed.ncbi.nlm.nih.gov

Safety and efficacy of flow re-direction endoluminal device (FRED) in the treatment of cerebral aneurysms: a single center experience. [2019]

6. England pubmed.ncbi.nlm.nih.gov

SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial. [2022]

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

FRED Flow Diverter: A Study on Safety and Efficacy in a Consecutive Group of 50 Patients. [2022]