WEB Device for Brain Aneurysm

(WEB PAS Trial)

Recruiting at 26 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

Trial Summary

What is the purpose of this trial?

A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

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 data supports the effectiveness of the WEB Device treatment for brain aneurysms?

Research shows that the WEB Device is effective in treating wide-necked intracranial aneurysms, with studies reporting positive outcomes in both safety and effectiveness for this type of brain aneurysm. ^{1 2 3 4 5}

How is the WEB Device treatment different from other treatments for brain aneurysms?

The WEB Device is unique because it is an intrasaccular flow diverter specifically designed for endovascular treatment of wide-necked bifurcation aneurysms, which means it is placed inside the aneurysm to help redirect blood flow and promote healing. Unlike traditional methods that may require additional devices like coils or stents, the WEB Device can be used on its own, offering a potentially simpler and less invasive option. ^{1 2 4 6 7}

Research Team

Adam Arthur, MD, MPH

Principal Investigator

Methodist University Hospital, Memphis TN

David Fiorella, MD

Principal Investigator

Stony Brook University, Stony Brook NY

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

References

1. United States 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. [2020]

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

Endovascular treatment of intracranial aneurysms using the Woven EndoBridge (WEB) device: retrospective analysis of a single center experience. [2020]

3. France pubmed.ncbi.nlm.nih.gov

The outcomes of recurrent wide-necked intracranial aneurysms treated with the Woven EndoBridge (WEB): A retrospective bicenter study. [2022]

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

The Woven Endobridge Device for Treatment of Intracranial Aneurysms: A Systematic Review. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Occlusion assessment of intracranial aneurysms treated with the WEB device. [2018]

6. Austria pubmed.ncbi.nlm.nih.gov

WEB-only treatment of ruptured and unruptured intracranial aneurysms: a retrospective analysis of 47 aneurysms. [2020]

7. United States 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. [2020]