WEB Device for Brain Aneurysm

(WEB PAS Trial)

Recruiting at 30 trial locations

Overseen By Amy Bowles

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Microvention-Terumo, Inc.

Disqualifiers: Ischemic stroke, Intracranial hemorrhage, Pregnancy, 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: 13

Duration: 1 day

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the WEB (Woven EndoBridge), designed to treat brain aneurysms. An aneurysm is a bulge in a blood vessel in the brain, and the WEB device seals this bulge by blocking blood flow, potentially preventing it from bursting. The trial aims to determine if the device successfully stops blood from entering the aneurysm over a year. It seeks adults with a single, untreated brain aneurysm. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance future aneurysm treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that the WEB Device is safe for treating brain aneurysms?

Research has shown that the WEB Aneurysm Embolization Device is generally safe for treating brain aneurysms. It effectively treats both ruptured and unruptured wide-neck bifurcation aneurysms. A thorough review confirmed that safety concerns have not led to its removal from the market.

Additionally, the FDA approved the WEB Device for treating certain types of aneurysms, indicating it meets safety standards for those conditions. However, ongoing research and user experiences remain important to ensure its safety in various situations. Overall, the WEB Device is well-tolerated, but like any treatment, further studies help confirm its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The WEB Aneurysm Embolization Device is unique because it offers a new way to treat brain aneurysms by using a metallic structure to line the aneurysm's neck. Unlike traditional treatments like surgical clipping or coil embolization, which require more invasive procedures or multiple coils, the WEB device directly targets blood flow into the aneurysm, promoting clotting and stabilizing the aneurysm from within. Researchers are excited about this treatment because it simplifies the procedure, potentially reduces recovery time, and minimizes the risks associated with more invasive surgeries.

What evidence suggests that the WEB device is effective for brain aneurysms?

Research has shown that the WEB Aneurysm Embolization Device, which participants in this trial will receive, effectively treats brain aneurysms. Studies have found that it prevents rebleeding, with a rebleeding rate of 0.0% at both one month and one year after treatment. The device functions by placing a metallic structure inside the aneurysm, stopping blood entry and causing clotting. Long-term results are positive for both burst and unburst aneurysms. The WEB device is recognized for its safety and effectiveness, and it remains on the market without safety-related withdrawals. ^{1 2 4 5 6}

Who Is on the Research Team?

Adam Arthur, MD, MPH

Principal Investigator

Methodist University Hospital, Memphis TN

David Fiorella, MD

Principal Investigator

Stony Brook University, Stony Brook NY

Are You a Good Fit for This Trial?

This study is for adults over 18 with brain aneurysms needing treatment, who can consent to participate. It's not for pregnant individuals, those with aneurysms unsuitable for endovascular treatment, high stroke risk patients, or anyone who had a recent subarachnoid hemorrhage from another aneurysm.

Inclusion Criteria

I have one aneurysm that needs treatment.

Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures

Exclusion Criteria

Patient is pregnant

I had a brain bleed not caused by my current aneurysm within the last 3 months.

My aneurysm cannot be treated with a less invasive procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the WEB Aneurysm Embolization Device for endovascular embolization of intracranial aneurysms

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcomes measured at 1 year

12 months

Multiple visits (in-person and virtual) over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• WEB

Trial Overview The trial tests the WEB Device's long-term safety and effectiveness in treating brain aneurysms. Participants will be observed to see if their aneurysm is adequately closed off at the one-year mark after receiving the device.

How Is the Trial Designed?

Group I: WEB Aneurysm Embolization Device Experimental Treatment 1 Intervention

WEB Aneurysm Embolization Device The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

WEB is already approved in European Union, United States for the following indications:

Approved in European Union as Woven EndoBridge for:

• Wide-neck bifurcation aneurysms (WNBA)
• Intracranial aneurysms

Approved in United States as Woven EndoBridge for:

• Wide-neck bifurcation aneurysms (WNBA)
• Intracranial aneurysms

Who Is Running the Clinical Trial?

Microvention-Terumo, Inc.

Lead Sponsor

Trials

32

Recruited

7,000+

Published Research Related to This Trial

In a study of 47 intracranial aneurysms treated solely with the WEB device, 91.4% achieved adequate occlusion, demonstrating its efficacy for both ruptured and unruptured aneurysms.

The WEB device showed a low retreatment rate of 6.3% and a manageable complication profile, with only 12.7% experiencing thromboembolic events, indicating it is a safe option for aneurysm treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WEB-only treatment of ruptured and unruptured intracranial aneurysms: a retrospective analysis of 47 aneurysms. Ozpeynirci, Y., Braun, M., Pala, A., et al.[2020]

The Woven EndoBridge (WEB) device was successfully implanted in 96.1% of the 102 treated aneurysms, demonstrating high technical feasibility in both ruptured and unruptured cases.

The device showed effective aneurysm occlusion rates of 80.7% at 3 months and 77.6% at 12 months, with a low complication rate of 4.9%, indicating it is a safe treatment option without the need for dual antiplatelet therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Center Experience in the Endovascular Treatment of Ruptured and Unruptured Intracranial Aneurysms Using the WEB Device: A Retrospective Analysis. Popielski, J., Berlis, A., Weber, W., et al.[2020]

The Woven EndoBridge (WEB) device was successfully used to treat 42 patients with intracranial aneurysms, achieving a high occlusion rate of 97% during a median follow-up of 7 months, indicating its efficacy for this condition.

There were no treatment-related complications or deaths reported, suggesting that the WEB device is a safe option for treating wide-necked bifurcation aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment of intracranial aneurysms using the Woven EndoBridge (WEB) device: retrospective analysis of a single center experience. Kaya, HE., Bakdık, S., Keskin, F., et al.[2020]

The Woven Endobridge (WEB) device shows promising efficacy for treating intracranial aneurysms, achieving successful treatment rates of 85% and 79% in the two largest studies involving 687 patients with 718 aneurysms.

However, caution is advised due to a significant learning curve associated with its use, potential thromboembolic events in 10.3% of patients, and the lack of long-term follow-up and direct comparisons with other treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Woven Endobridge Device for Treatment of Intracranial Aneurysms: A Systematic Review. Muskens, IS., Senders, JT., Dasenbrock, HH., et al.[2018]

In a study of 22 patients with 23 recurrent intracranial aneurysms treated with the Woven EndoBridge (WEB) device, 87% achieved adequate occlusion (RROC I and II) after treatment, indicating its effectiveness for this challenging condition.

The treatment was associated with a low complication rate, with only one patient (5%) experiencing a hemorrhagic complication two weeks post-treatment, suggesting that WEB is a safe option for recurrent wide-necked aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outcomes of recurrent wide-necked intracranial aneurysms treated with the Woven EndoBridge (WEB): A retrospective bicenter study. Alpay, K., Nania, A., Parkkola, R., et al.[2022]

The Woven EndoBridge (WEB) device was used in a study involving 11 patients with recurrent or residual aneurysms, showing that WEB embolization is feasible and reasonably safe, with only one complication (a perforation that resolved without issues).

At a median follow-up of 6 months, 78% of patients achieved near-complete occlusion of their aneurysms, indicating that while the treatment is effective, careful selection of aneurysms is important for optimizing occlusion rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Recurrent and Residual Aneurysms with the Woven EndoBridge Device: Analysis of 11 Patients and Review of the Literature. Kabbasch, C., Goertz, L., Siebert, E., et al.[2020]

The study evaluated the Woven EndoBridge (WEB) system for treating wide-neck bifurcation intracranial aneurysms, finding that the WEB Occlusion Scale (WOS) provided a reliable method for assessing the device's effectiveness, with an 'almost perfect' inter-rater agreement (kappa = 0.88) when using a dichotomized scale for complete occlusion.

The use of C-Arm VasoCT imaging significantly improved agreement among raters in evaluating occlusion, particularly in identifying residual filling within the WEB device, highlighting its importance in clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occlusion assessment of intracranial aneurysms treated with the WEB device. Caroff, J., Mihalea, C., Tuilier, T., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8423055/

Safety and Efficacy of the Woven EndoBridge Device for ... This meta-analysis demonstrated the safety and efficacy of the Woven EndoBridge device in the management of ruptured aneurysms, but further studies are needed.

2. nature.com nature.com/articles/s41598-024-75064-2

Lessons learned from 12 years using the Woven ... Long-term clinical and angiographic outcome of the Woven EndoBridge (WEB) for endovascular treatment of intracranial aneurysms. Article Open ...

3. jnis.bmj.com jnis.bmj.com/content/17/11/1138

a transformative journey in aneurysm treatment 6 This study clearly showed that the WEB device protected these patients against rebleeding at 1 month and 1 year with a rebleeding rate of 0.0% for both ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170032B.pdf

summary of safety and effectiveness data (ssed) The WEB Aneurysm Embolization System has not been withdrawn from marketing for any reason related to its safety or effectiveness. VIII. PROBABLE ...

5. thejns.org thejns.org/view/journals/j-neurosurg/136/5/article-p1266.xml

feasibility, techniques, and outcomes after FDA approval in The WEB device has been successfully used for the treatment of both unruptured and ruptured wide-neck bifurcation aneurysms by achieving intrasaccular flow ...

6. jnis.bmj.com jnis.bmj.com/content/11/9/924

The safety and effectiveness of the Woven EndoBridge ... The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently ...