Pipeline™ Shield Device for Brain Aneurysm

Not currently recruiting at 16 trial locations

Overseen By Medtronic Neurovascular Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Neurovascular Clinical Affairs

Disqualifiers: Pregnancy, Breastfeeding, Inaccessible, others

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: Unknown

Duration: Institutional routine clinical care

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies the Pipeline™ Flex Embolization Device with Shield Technology™, used to treat intracranial aneurysms (bulges in blood vessels in the brain). The goal is to evaluate the device's performance in real-world settings across the United States. Individuals already selected to receive this device for aneurysm treatment may be suitable for this trial. The study aims to gather information on the device's safety and effectiveness after its approval for use. As a Phase 4 trial, this research helps determine how the FDA-approved treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

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

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

Research has shown that the Pipeline™ Flex Embolization Device with Shield Technology™ is generally safe. In one study, over six months, the device demonstrated a low rate of complications during the procedure and none afterward, indicating that most patients tolerate it well. The device is already approved for treating bulging blood vessels in the brain, supporting its safety for this use. Although complications can occur with any medical device, evidence suggests these are rare. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Pipeline™ Flex Embolization Device with Shield Technology™ is unique because it specifically targets brain aneurysms by diverting blood flow away from the aneurysm, promoting thrombosis, or clotting, within the aneurysm itself. Unlike traditional treatments that may require invasive surgery, this device is minimally invasive, which can mean a quicker recovery and fewer complications for patients. Researchers are excited about this treatment because the Shield Technology™ offers an advanced surface modification that may reduce the risk of blood clots forming on the device, potentially making it safer and more effective than existing options.

What evidence suggests that the Pipeline™ Flex Embolization Device with Shield Technology™ is effective for treating intracranial aneurysms?

Studies have shown that the Pipeline™ Flex Embolization Device with Shield Technology™ effectively treats unruptured brain aneurysms. Research indicates that the device redirects blood flow away from the aneurysm, promoting natural healing. In one study, patients using this device showed positive results after one year, demonstrating successful aneurysm treatment. Another study found the device to be safe, with fewer complications. Overall, the Pipeline Shield Device has proven to be a safe and effective treatment option for this condition. ^{1 3 6 7 8}

Who Is on the Research Team?

Harsh Sancheti

Principal Investigator

Medtronic

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.

Patient is consented within the enrollment window of the therapy received, as applicable.

Patient or patient's legally authorized representative (LAR) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with the study requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo treatment for intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™

Institutional routine clinical care

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Pipeline™ Flex Embolization Device with Shield Technology™

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?

Medtronic Neurovascular Clinical Affairs

Lead Sponsor

Trials

32

Recruited

10,000+

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/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 ...

3. 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.

4. 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.

5. 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.

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

Pipeline™ Flex Embolization Device The safety and effectiveness of the device has not been evaluated or demonstrated for ruptured aneurysms . POTENTIAL COMPLICATIONS. Potential complications ...

7. bfarm.de bfarm.de/SharedDocs/Kundeninfos/EN/11/2025/03193-25_kundeninfo_en.pdf?__blob=publicationFile

Pipeline™ Vantage Embolization Device with Shield™ ... INSPIRE-A includes monitored data on 423 patients treated with the Pipeline Vantage Embolization Device with Shield Technology. (“Pipeline Vantage”) and 530 ...

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

A Study of the Pipeline™ Vantage Embolization DeVice with The Pipeline™ Vantage Embolization Device with Shield Technology™ is intended for endovascular treatment of adults (22 years of age or older) with wide-necked ...