Endovascular Treatment for Brain Aneurysm

(ELEVATE Trial)

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

Must not be taking: Anticoagulants, Ticagrelor, Aspirin, others

Disqualifiers: Intraparenchymal hemorrhage, Malignant brain tumor, 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: 4

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Pipeline™ Flex Embolization Device with Shield Technology™ to evaluate its safety and effectiveness in treating ruptured brain aneurysms. A brain aneurysm is a weak spot in a blood vessel in the brain that can burst and cause bleeding. The trial targets aneurysms unsuitable for traditional treatments like surgery or coiling. Suitable participants have a specific type of untreated brain aneurysm that has recently ruptured and cannot be addressed with standard treatments. As an unphased trial, this study provides patients access to innovative treatment options not yet widely available.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you require continuous anti-coagulation, you may not be eligible to participate.

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

Research has shown that the Pipeline™ Flex Embolization Device with Shield Technology™ is generally safe. One study demonstrated a strong safety record over six months, with some complications occurring during the procedure but none afterward. Another study found few negative effects after one year, indicating it is well-tolerated. These results suggest the device is safe for treating brain aneurysms. However, like any medical procedure, there is always a risk of complications. Discuss these risks with your doctor. ^{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 minimally invasive approach to treating brain aneurysms, which can be a significant advancement over traditional surgical options like clipping or coiling. Unlike these methods, which require direct access to the aneurysm through open surgery or catheter insertion, the Pipeline™ Flex device uses advanced flow diversion technology to redirect blood flow away from the aneurysm, promoting natural healing and reducing the risk of rupture. Researchers are particularly excited about the Shield Technology™, as it may enhance biocompatibility and reduce complications, providing a safer and potentially more effective treatment for patients with brain aneurysms.

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

Research has shown that the Pipeline™ Flex Embolization Device with Shield Technology™ effectively treats brain aneurysms. Studies have found that this device often completely seals off aneurysms, successfully blocking them. Other research suggests it is safe, making it a dependable choice for patients. Additionally, the device's design improves treatment results, especially compared to older versions. While most research focuses on unruptured aneurysms, early results are promising for its use in cases where aneurysms have suddenly burst. Participants in this trial will receive the Pipeline™ Flex Embolization Device with Shield Technology™ as part of a prospective, single-arm study. ^{1 2 4 6 7}

Who Is on the Research Team?

David Fiorella, MD

Principal Investigator

Stony Brook University Hospital

Adam Arthur, MD

Principal Investigator

Semmes Murphey Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 22-80 with a specific type of untreated brain aneurysm that's unsuitable for surgery or coiling. Participants must have had a recent rupture rated Hunt and Hess Scale 1-3, without serious comorbidities, allergies to device materials, or conditions preventing study procedures and follow-ups.

Inclusion Criteria

My aneurysm has not been treated and is difficult to treat with surgery or coiling.

I have a recently burst aneurysm and my condition is mild to moderate.

Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent.

Exclusion Criteria

I need to be on blood thinners all the time.

I have a malignant brain tumor or a vascular malformation.

You have a stent in the main artery near the aneurysm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Deployment of the Pipeline™ Flex Embolization Device with Shield Technology™ is attempted for the treatment of acutely ruptured intracranial aneurysms

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 visits (in-person) at 30-day, 180-day, and 365-day post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Pipeline™ Flex Embolization Device with Shield Technology™

Trial Overview The Pipeline™ Flex Embolization Device with Shield Technology™ is being tested for safety and effectiveness in treating acutely ruptured intracranial aneurysms. The study aims to see if this device can be a viable treatment option.

How Is the Trial Designed?

Group I: Pipeline™ Flex Embolization Device with Shield Technology™ Experimental Treatment 1 Intervention

This is a prospective, single-arm study in which subjects have consented and deployment of the Pipeline™ Flex Embolization Device with Shield Technology™ is attempted.

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+

Published Research Related to This Trial

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 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]

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 modified Pipeline Vantage Embolization Device demonstrated a high technical success rate of 98% in treating 60 aneurysms across 52 procedures, indicating its efficacy in aneurysm occlusion.

Safety outcomes were acceptable, with 83% of patients achieving adequate aneurysm occlusion at follow-up, and while there were some complications, the rates were comparable to earlier generation devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes of the Pipeline Vantage Flow Diverter : A Multicentre Study. Sciacca, S., Bassiouny, A., Mansoor, N., et al.[2023]

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 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]

Citations

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

Pipeline Flex embolisation device with Shield Technology ... This study summarises periprocedural outcomes and 6-month follow-up results following its introduction in a tertiary interventional neuroradiology centre.

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 ...