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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the Pipeline™ Flex Embolization Device with Shield Technology™, designed to treat wide-necked brain aneurysms (bulges in blood vessels) in adults. The researchers aim to assess the device's effectiveness in treating these aneurysms and its ability to prevent issues like blood clots. Suitable candidates have large or giant wide-necked aneurysms in specific areas of the brain's internal carotid artery. Participants must be able to provide consent to join the study. As an unphased trial, this study allows patients to contribute to important research that could enhance treatment options for brain 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 prior data suggests that this device is safe for treating brain aneurysms?

Research has shown that the Pipeline™ Flex Embolization Device with Shield Technology™ is generally safe for treating brain aneurysms. Studies have demonstrated its strong safety record. For instance, one study reported no complications after the procedure and minimal complications during it, indicating that most patients tolerate it well.

Another study found that the device continues to deliver good results over time, with low risks associated with its use. Additionally, when considering long-term safety, the device effectively treats unruptured brain aneurysms, which are bulging blood vessels in the brain that haven't burst.

Overall, these findings suggest that the Pipeline™ Flex Embolization Device with Shield Technology™ is a safe option for those considering treatment for brain aneurysms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Pipeline™ Flex Embolization Device with Shield Technology™ is unique because it offers a novel approach to treating brain aneurysms. Unlike traditional treatments, such as surgical clipping or coiling, this device works by diverting blood flow away from the aneurysm, encouraging it to heal naturally. Its Shield Technology™ reduces the risk of thromboembolic events, which is a common complication with current methods. Researchers are excited because this could mean a safer, more effective option for patients with complex aneurysms.

What evidence suggests that this device is effective for brain aneurysms?

Research has shown that the Pipeline™ Flex Embolization Device with Shield Technology™ holds promise for treating wide-necked brain aneurysms. Studies have found that this device often completely blocks the aneurysm, helping to prevent it from bursting. The device carries a low risk of complications, such as blood clots, and is considered safe. Overall, the Pipeline Flex Device is regarded as a safe and effective option for treating certain brain aneurysms. Participants in this single-arm study will receive the Pipeline Flex Device to further evaluate its effectiveness and safety. ^{2 4 6 7 8}

Who Is on the Research Team?

Elad LEvy, MD

Principal Investigator

University at Buffalo Neurosurgery

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7788678/

Pipeline Flex embolisation device with Shield Technology ... This prospective, single-arm study assessed 32 aneurysms treated over a 21-month time period from the time of procedure to 6 months post-procedure. Data ...

2. jnis.bmj.com jnis.bmj.com/content/16/11/1136

Outcome study of the Pipeline Vantage Embolization Device ... For unruptured aneurysm treatment, the second PEDV version appears to have a superior efficacy and similar safety profile to previous-generation PEDs.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/14/NCT03873714/Prot_SAP_000.pdf

A Study of the Pipeline™ Vantage Embolization DeVice with Both. SHIELD OUS and PFLEX studies achieved a high rate of complete aneurysm occlusion with the use of the. Pipeline™ Flex Embolization Device with Shield ...

4. ajnr.org ajnr.org/content/early/2025/02/25/ajnr.A8719

Efficacy and safety in the use of Pipeline Vantage Shield ... The PEDV stent improved efficacy in comparison with PED-Shield stent at 12-months while the PED-Shield stent showed a slightly better safety profile.

5. europe.medtronic.com europe.medtronic.com/xd-en/healthcare-professionals/products/neurological/aneurysm-treatment/pipeline-shield.html

Pipeline™ Vantage and Flex Flow Diverters Efficacy Setting the bar for safe & effective aneurysm treatment. Our Pipeline Embolization Device Family consistently achieves high complete occlusion rates ...

6. medtronic.com medtronic.com/en-us/healthcare-professionals/products/neurological/neurovascular/aneurysm-flow-diverters/pipeline-flex-with-shield-technology.html

Pipeline™ Flex with Shield Technology™ Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100018S015C.pdf

Pipeline™ Flex Embolization Device The risk of rupture for small and medium asymptomatic extradural intracranial aneurysms is very low if not negligible . • A decrease in the proportion of ...

8. ahajournals.org ahajournals.org/doi/10.1161/SVIN.121.000292

Safety and Clinical Effectiveness of Pipeline Shield Device ... We report the long‐term safety and effectiveness of the PED‐Shield in the treatment of unruptured intracranial aneurysms in an Australian cohort.