Endovascular Repair Techniques for Brain Aneurysm

(RISE Trial)

Recruiting at 3 trial locations

Overseen By daniela E Iancu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Surgery contraindication, Informed consent, others

Stay on Your Current Meds You can continue your current medications while participating

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: 2

Duration: 1 week

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that the WEB technique does not require anti-platelet therapy. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Woven EndoBridge (WEB) device for brain aneurysms?

The Woven EndoBridge (WEB) device is shown to be effective for treating wide-necked intracranial aneurysms, especially bifurcation aneurysms, as it allows for safe treatment without the need for dual antiplatelet therapy. Studies have evaluated its safety and effectiveness, with positive outcomes reported in both single-center experiences and systematic reviews. ^{1 2 3 4 5}

Is the WEB embolization device safe for treating brain aneurysms?

Thromboembolic (blood clot-related) and hemorrhagic (bleeding-related) complications are significant safety concerns in endovascular treatments for aneurysms, including those using devices like the WEB embolization device. ^{6 7 8 9 10}

How does the WEB device treatment for brain aneurysms differ from other treatments?

The Woven EndoBridge (WEB) device is unique because it allows for the treatment of wide-neck bifurcation aneurysms without the need for dual antiplatelet therapy, which is often required in other treatments. This device is placed inside the aneurysm to block blood flow, reducing the risk of rupture, and is particularly useful for patients who are not ideal candidates for traditional methods like surgical clipping or coiling. ^{3 4 5 11 12}

What is the purpose of this trial?

Intracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed. One particularly promising innovation is the WEB (Woven EndoBridge), which permits placement of an intra-saccular flow diverting mesh across the aneurysm neck, but which does not require anti-platelet agent therapy. Currently, which treatment option leads to the best outcome for patients with WNBA remains unknown. There is a need to offer treatment with the WEB within the context of a randomized care trial, to patients currently presenting with aneurysms thought to be suitable for the WEB.

Eligibility Criteria

The RISE Trial is for patients with brain aneurysms suitable for a device called WEB. It's open to those with aneurysms 4-11 mm wide, including recurring ones if the shape fits treatment criteria. People can't join if they have contraindications to surgery or anesthesia, can't consent, or have very small (≤4mm) or large (≥11mm) aneurysms.

Inclusion Criteria

I have a brain aneurysm located at a major artery junction.

My aneurysm is between 4 and 11 mm in size.

My aneurysm is located in a major brain artery.

Exclusion Criteria

I have a severe ruptured aneurysm.

I am unable to understand and give consent for treatment.

I cannot undergo surgery or anesthesia due to severe health risks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the WEB embolization device or standard conventional treatment, which may include surgical clipping, coiling, or stenting

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, with evaluations including modified Rankin Scale assessments and imaging to assess aneurysm occlusion

12 months

Multiple visits (in-person) at 1 week, 1-3 months, and 12 months post-treatment

Treatment Details

Interventions

• WEB embolization device

Trial Overview This trial tests different treatments for brain aneurysms: the WEB device that doesn’t need anti-platelet drugs, surgical clipping, coiling techniques, stenting and flow diversion methods. The best approach for wide-necked bifurcation aneurysms is being studied.

Participant Groups

Group I: WEB embolization device Experimental Treatment 1 Intervention

Endovascular treatment with WEB, including standard management of thrombo-embolic risk

Group II: Standard conventional treatment (surgical or endovascular) Active Control 1 Intervention

Treatment may include the most appropriate amongst surgical clipping, simple coiling, high-porosity stenting with or without coiling, and intra-arterial flow diversion with or without coiling, which will be predetermined by the treating physician prior to randomization.

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

Approved in United States as Woven EndoBridge for:

• Treatment of wide-necked bifurcation aneurysms (WNBAs) at the middle cerebral artery (MCA) bifurcation, internal carotid artery terminus, anterior communicating artery complex, or basilar artery apex

Approved in European Union as Woven EndoBridge for:

• Treatment of wide-necked bifurcation aneurysms (WNBAs)

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Findings from Research

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 successfully achieved complete occlusion in 62.2% of treated wide-necked intracranial aneurysms, indicating its efficacy as a treatment option for this complex condition.

Factors such as larger aneurysm size, initial partial thrombosis, and combined treatment with coils were linked to lower occlusion rates and higher recurrence, suggesting that these anatomical and procedural characteristics should be carefully considered when using the WEB device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that determine aneurysm occlusion after embolization with the Woven EndoBridge (WEB). Kabbasch, C., Goertz, L., Siebert, E., et al.[2019]

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 is a promising new technology for treating wide-neck bifurcation aneurysms safely without requiring dual antiplatelet therapy, which is beneficial for patients on anticoagulants like warfarin.

In a case study involving a patient with a complex medical history, a technical error during the procedure was successfully corrected, demonstrating the device's adaptability and effectiveness in restoring its shape and function, with positive follow-up results after 4 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Snare salvage technique for deformed WEB device after deployment. Aljuboori, Z., Ding, D., James, RF.[2021]

Thromboembolic events are the most significant adverse effect associated with coil embolization for treating intracerebral aneurysms.

The study aimed to identify risk factors for these thromboembolic events by using diffusion-weighted imaging (DWI) to compare both unruptured and ruptured aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thromboembolic Events during Endovascular Coil Embolization of Cerebral Aneurysms. Ishibashi, T., Murayama, Y., Saguchi, T., et al.[2021]

The use of the MedWatcher app, combined with outreach to a Facebook patient community, significantly reduced the time to submit adverse event reports for the Essure device, averaging only 11.4 minutes compared to the typical 40 minutes for traditional methods.

Patients reported a high number of serious adverse events (77.6% of submissions), including hospitalization and permanent damage, and the reports submitted via the app were found to be 15 times more frequent than those through traditional reporting channels, indicating improved engagement and reporting quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US. Bahk, CY., Goshgarian, M., Donahue, K., et al.[2019]

The study identified that about 60% of the terms used in Japanese medical device adverse event reports were duplicated due to multiple industry associations using the same terminology, highlighting a significant inconsistency in the terminology used.

Using RDF and SPARQL proved effective in uncovering inconsistencies in the hierarchy, definitions, and synonyms of the terms, with only about 10% of terms needing further review, thus streamlining the integration process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Terminology integration and inconsistency identification of adverse event terminology for Japanese medical devices using SPARQL. Yagahara, A., Yokoi, H.[2022]

In a study comparing 50 patients treated with ticagrelor and 53 patients treated with clopidogrel during flow diverter device procedures, both medications showed similar rates of thromboembolic and hemorrhagic complications, indicating that ticagrelor is a safe alternative.

While ticagrelor is effective in preventing complications after aneurysm treatment, it is significantly more expensive than clopidogrel, suggesting it should be used primarily for patients who do not respond well to clopidogrel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter Cohort Comparison Study of the Safety, Efficacy, and Cost of Ticagrelor Compared to Clopidogrel in Aneurysm Flow Diverter Procedures. Moore, JM., Adeeb, N., Shallwani, H., et al.[2022]

A significant portion of medical device adverse event reports submitted to the FDA's MAUDE database (approximately 47.9%) were classified as categories other than death, despite containing terms indicating that a patient had died.

The study found that about 23% of reports involving patient deaths were misclassified, suggesting that around 31,552 reports may have inaccurately categorized deaths, highlighting a critical need for improved accuracy in adverse event reporting to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death. Lalani, C., Kunwar, EM., Kinard, M., 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 Woven Endobridge (WEB) device was successfully used in 22 out of 23 interventions for treating unruptured wide-neck aneurysms, demonstrating its feasibility even in challenging cases where traditional methods were not suitable.

Follow-up results showed that 19 out of 22 aneurysms achieved total or subtotal occlusion, indicating promising effectiveness and a low risk of complications over a mid-term follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Woven Endobridge (WEB) device for endovascular treatment of complex unruptured aneurysms-a single center experience. Lescher, S., du Mesnil de Rochemont, R., Berkefeld, J.[2018]

References

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

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

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Factors that determine aneurysm occlusion after embolization with the Woven EndoBridge (WEB). [2019]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

Snare salvage technique for deformed WEB device after deployment. [2021]

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

Thromboembolic Events during Endovascular Coil Embolization of Cerebral Aneurysms. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Terminology integration and inconsistency identification of adverse event terminology for Japanese medical devices using SPARQL. [2022]

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

A Multicenter Cohort Comparison Study of the Safety, Efficacy, and Cost of Ticagrelor Compared to Clopidogrel in Aneurysm Flow Diverter Procedures. [2022]

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

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death. [2022]

11. 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]

12. Germany pubmed.ncbi.nlm.nih.gov

Woven Endobridge (WEB) device for endovascular treatment of complex unruptured aneurysms-a single center experience. [2018]