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

10 Participants Needed

Trial Summary

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 data supports the effectiveness of the SHIELD Device for Brain Aneurysm treatment?

The Pipeline Flex Embolization Device with Shield Technology has shown positive outcomes in treating brain aneurysms, with studies indicating it reduces the risk of blood clots forming inside the blood vessels. It has been reported to be safe and effective in both short-term and long-term follow-ups for patients with unruptured brain aneurysms. ^{1 2 3 4 5}

What makes the SHIELD Device for Brain Aneurysm treatment unique?

The SHIELD Device for Brain Aneurysm treatment is unique because it uses the Pipeline™ Flex Embolization Device with Shield Technology™, which is designed to provide a minimally invasive approach to treating brain aneurysms by diverting blood flow away from the aneurysm, potentially reducing the risk of rupture. ^{6 7 8 9 10}

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

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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

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

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

2. 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]

3. England 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. [2023]

4. 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]

5. England 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. [2020]

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

A tongue-shielding radiation stent. [2019]

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

Miniaturized osmotic pump for oromucosal drug delivery with external readout station. [2020]

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

3-D flexible nano-textured high-density microelectrode arrays for high-performance neuro-monitoring and neuro-stimulation. [2014]

9. Germany pubmed.ncbi.nlm.nih.gov

An in vitro evaluation of a prototype Delrin carrier for the Thermafil obturation system. [2021]

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

Soft implantable drug delivery device integrated wirelessly with wearable devices to treat fatal seizures. [2022]