FRED™ X™ Device for Brain Aneurysm

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Microvention-Terumo, Inc.

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

Disqualifiers: Intracranial hemorrhage, Cardiac embolism, others

No Placebo Group

Approved in 2 Jurisdictions

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}

Research Team

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.

Trial 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™ (Flow Diverters)

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

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]

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]

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]