Endovascular Treatment for Brain Aneurysm

(ELEVATE Trial)

Recruiting at 15 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: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.

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 data supports the effectiveness of the treatment Pipeline Flex Embolization Device with Shield Technology for brain aneurysms?

Research shows that the Pipeline Flex Embolization Device with Shield Technology is effective in treating brain aneurysms by reducing the risk of blood clots (thrombogenicity) and improving the healing of the blood vessel lining (endothelialization). Studies have reported positive outcomes in both safety and effectiveness, with improvements seen in the closure of aneurysms and reduced complications during and after the procedure. ^{1 2 3 4 5}

Is the Pipeline Embolization Device with Shield Technology safe for humans?

The Pipeline Embolization Device with Shield Technology has been evaluated for safety in several studies. It is designed to reduce the risk of blood clots (thrombogenicity) and has shown early technical success and safety in treating brain aneurysms, with follow-up studies confirming its safety over time. ^{1 2 3 6 7}

What makes the Pipeline Flex Embolization Device with Shield Technology unique for treating brain aneurysms?

The Pipeline Flex Embolization Device with Shield Technology is unique because it is a flow diverter with a special surface modification that reduces the risk of blood clots forming inside the blood vessel, making it safer for treating brain aneurysms. ^{1 2 3 4 5}

Research Team

David Fiorella, MD

Principal Investigator

Stony Brook University Hospital

Adam Arthur, MD

Principal Investigator

Semmes Murphey Clinic

Eligibility Criteria

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.

I am between 22 and 80 years old.

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology. [2020]

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

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

3. 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]

4. 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]

5. 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]

6. 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]

7. Germany pubmed.ncbi.nlm.nih.gov

Early Outcomes of the Pipeline Vantage Flow Diverter : A Multicentre Study. [2023]