Flow Diverter Device for Brain Aneurysm

(SHIELD Trial)

Overseen By Jennifer Gay, BA, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Inability to consent

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: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The Jacobs Institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with wide-necked intracranial aneurysms

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Pipeline Flex Embolization Device with Shield Technology for brain aneurysms?

Research shows that the Pipeline Flex Embolization Device with Shield Technology is effective in treating brain aneurysms by reducing the risk of blood clots and promoting healing of the blood vessel lining. Studies have reported positive outcomes, including successful closure of aneurysms and low complication rates. ^{1 2 3 4 5}

What makes the Pipeline Flex Embolization Device with Shield Technology unique for treating brain aneurysms?

The Pipeline Flex Embolization Device with Shield Technology is unique because it is a flow diverter designed to reduce the risk of blood clots (thrombogenicity) and promote healing of the blood vessel lining (endothelialization), making it more effective in closing aneurysms compared to previous devices. ^{1 2 3 4 5}

Research Team

Elad LEvy, MD

Principal Investigator

University at Buffalo Neurosurgery

Eligibility Criteria

This trial is for adults aged 22 or older with wide-necked intracranial aneurysms. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

I am 22 or older with a large aneurysm in a specific part of my brain.

Exclusion Criteria

I am able to give my own consent for treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Pipeline™ Flex Embolization Device for the endovascular treatment of intracranial aneurysms

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person)

Treatment Details

Interventions

• Pipeline™ Flex Embolization Device with Shield Technology™

Trial Overview The study is evaluating the Pipeline™ Flex Embolization Device with Shield Technology™, which is a device designed to treat brain aneurysms by diverting blood flow away from them.

Participant Groups

Group I: Single arm study Experimental Treatment 1 Intervention

Occurrence of thromboembolic event(s)

Pipeline™ Flex Embolization Device with Shield Technology™ is already approved in United States, European Union for the following indications:

Approved in United States as Pipeline Flex Embolization Device with Shield Technology for:

• Endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments
• Endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter 2.0 mm and ≤ 5.0 mm

Approved in European Union as Pipeline Flex Embolization Device with Shield Technology for:

• Endovascular embolization of cerebral aneurysms

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Jacobs institute

Collaborator

Trials

3

Recruited

30+

Findings from Research

The Pipeline Vantage Embolization Device demonstrated improved endothelial coverage and lower thrombogenicity compared to the Pipeline Flex device, indicating better safety and efficacy in treating aneurysms.

In a rabbit model study involving 29 and 27 subjects at 90 and 180 days respectively, Vantage showed a higher rate of aneurysm occlusion and significantly reduced thrombin generation and platelet activation, suggesting it may be a more effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology. Starke, RM., Thompson, J., Pagani, A., et al.[2020]

The Pipeline Flex Embolization Device with Shield Technology demonstrated a high aneurysm occlusion rate of 90.3% at 18 months, indicating its efficacy in treating aneurysms, particularly saccular ones.

The safety profile was favorable, with low cumulative mortality (2.3%) and morbidity (6.8%) rates at one year, comparable to earlier generation flow-diverter devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU). Atasoy, D., Kandasamy, N., Hart, J., et al.[2021]

The Pipeline Flex embolisation device with Shield Technology demonstrated a strong safety profile in a study of 32 aneurysms, with only a 6.2% rate of periprocedural complications and no mortality reported.

At the 6-month follow-up, 90.6% of aneurysms showed satisfactory occlusion, indicating the device's efficacy in effectively treating aneurysms without significant complications or recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pipeline Flex embolisation device with Shield Technology for the treatment of patients with intracranial aneurysms: periprocedural and 6 month outcomes. Yeomans, J., Sandu, L., Sastry, A.[2021]

The Pipeline Flex Embolization Device with Shield technology (PED-Shield) showed excellent performance in treating 11 unruptured wide-necked intracranial aneurysms in a small cohort of 10 patients, with no major complications reported during the procedure.

While there were minor complications, such as a groin hematoma and a small intracranial hemorrhage, these did not have clinical repercussions, suggesting the device is safe for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First U.S. Experience Using the Pipeline Flex Embolization Device with Shield Technology for Treatment of Intracranial Aneurysms. Cappuzzo, JM., Monteiro, A., Taylor, MN., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology. [2020]

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

Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU). [2021]

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

Pipeline Flex embolisation device with Shield Technology for the treatment of patients with intracranial aneurysms: periprocedural and 6 month outcomes. [2021]

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

Early clinical experience with the new generation Pipeline Vantage flow diverter in the treatment of unruptured saccular aneurysms using short-term dual antiplatelet therapy. [2023]

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

First U.S. Experience Using the Pipeline Flex Embolization Device with Shield Technology for Treatment of Intracranial Aneurysms. [2022]