SHIELD Device for Brain Aneurysm

(SHIELD Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Carlos Pena, PhD, MS

Disqualifiers: Cannot provide consent, others

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

Compensation: Varies

Number of Visits: 1

Duration: Procedure duration

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Pipeline™ Flex Embolization Device with Shield Technology™, designed to treat adults with large or giant brain aneurysms, particularly in the internal carotid artery. The goal is to gather data on the device's effectiveness in treating these aneurysms. Adults aged 22 or older with a diagnosed wide-necked intracranial aneurysm may qualify for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative device.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Pipeline™ Flex Embolization Device with Shield Technology™ is safe for treating wide-necked intracranial aneurysms?

Research has shown that the Pipeline™ Flex Embolization Device with Shield Technology™ is generally safe. One study demonstrated a very good safety record six months post-use, with no problems after the procedure and only a few issues during it. Another study examined patients over a longer period and found the device safe and effective for treating unruptured brain aneurysms. This study reported high success in sealing the aneurysms and few complications. These results suggest the device is well-tolerated by patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The Pipeline™ Flex Embolization Device with Shield Technology™ is unique because it represents a new approach to treating brain aneurysms. Unlike traditional surgical options or coil embolization, which physically fill the aneurysm to prevent rupture, this device uses a minimally invasive technique to redirect blood flow away from the aneurysm, promoting natural healing over time. Researchers are excited about this treatment because the Shield Technology™ is designed to reduce the risk of blood clot formation on the device, potentially leading to safer outcomes for patients.

What evidence suggests that the SHIELD Device is effective for brain aneurysms?

Research has shown that the Pipeline™ Flex Embolization Device with Shield Technology™ effectively treats wide-necked brain aneurysms. Participants in this trial will receive active treatment with this device. Studies have found it to be very safe over six months, with few complications during and after the procedure. One study reported good safety and effectiveness up to one year. The device reduces the risk of blood clots, enhancing its effectiveness in treating aneurysms. Experts emphasize its effectiveness and safety for patients with these conditions. ^{4 5 6 7 8}

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 be in stable health and meet certain medical requirements specific to the study.

Inclusion Criteria

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

Exclusion Criteria

I am unable to give consent and do not have a legal representative to do so on my behalf.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Active treatment with the Pipeline SHIELD Device for endovascular treatment of intracranial aneurysms

Procedure duration

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Pipeline™ Flex Embolization Device with Shield Technology™

Trial Overview The SHIELD clinical trial is testing the Pipeline™ Flex Embolization Device with Shield Technology™. This device is designed for endovascular treatment of brain aneurysms, aiming to prevent rupture by diverting blood flow.

How Is the Trial Designed?

Group I: SHIELD Study Arm Experimental Treatment 1 Intervention

Active treatment with the Pipeline SHIELD Device

Who Is Running the Clinical Trial?

Carlos Pena, PhD, MS

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

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]

In a study involving 50 patients treated with the Pipeline Shield for unruptured intracranial aneurysms, there were no major strokes or neurologic deaths reported at the 1-year follow-up, indicating a high level of safety for this treatment.

The Pipeline Shield achieved complete occlusion in 81.8% of cases, with no instances of aneurysm recurrence or the need for retreatment, demonstrating its efficacy in managing intracranial aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up. Martínez-Galdámez, M., Lamin, SM., Lagios, KG., et al.[2020]

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]

In a study of 89 patients with brain aneurysms, the Pipeline Flex embolization device and the Pipeline Flex with Shield technology showed no significant difference in the occurrence of perioperative diffusion-weighted imaging positive (DWI+) lesions, indicating similar safety profiles regarding thrombogenicity.

Both devices resulted in a high incidence of DWI+ lesions (61% for PED Flex and 62% for PED Shield), suggesting that the new Shield technology does not reduce the risk of these lesions compared to the standard device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffusion-weighted imaging lesions after intracranial aneurysm treatment with Pipeline Flex and Pipeline Flex with Shield technology: a retrospective cohort analysis. Cortez, GM., Benalia, VHC., Sauvageau, E., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33092461/

Pipeline Flex embolisation device with Shield Technology ... The Pipeline Shield has an excellent 6- month safety profile with an acceptable rate of intraprocedural complications, no post-procedure ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02719522

Pipeline Flex With SHield Technology Embolization Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective ...

3. jnis.bmj.com jnis.bmj.com/content/early/2025/05/21/jnis-2025-023229

a propensity score-matched retrospective cohort study The Pipeline Flex embolization device with Shield technology (PED Shield) is a flow diverter designed to reduce thrombogenicity through ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.971664/full

Clinical outcomes of pipeline embolization devices with ... This review demonstrates the safety and efficacy of the pipeline shield for treating intracranial aneurysms.

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100018S015B.pdf

summary of safety and effectiveness data (ssed) The Pipeline™ Flex Embolization Device features a modified device delivery system compared to the original Pipeline™ Embolization Device, and was approved ...

6. 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.

7. jnis.bmj.com jnis.bmj.com/content/12/11/1107

Periprocedural to 1-year safety and efficacy outcomes with ... The findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of ...

8. 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™ Study shows that Pipeline™ Flex with Shield Technology™ is safe and effective for the treatment of intracranial aneurysms. 0% target aneurysm recurrence3; 0% ...