Comparing WEB and other treatments for ruptured aneurysms
Official title: WEB™ Embolization System in the Treatment of Acutely Ruptured Intracranial Aneurysms Versus Other Endovascular Techniques
Run by Microvention-Terumo, Inc. · NCT06511245 · Data updated 2026-11-12
This study is testing whether a new device called WEB works better than other treatments for people with ruptured brain aneurysms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Microvention-Terumo, Inc. Industry-sponsored |
| Locations | 1 site (Reims) |
| Status | Recruiting |
| Started | October 2, 2024 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | December 18, 2024 |
| Trial ID | NCT06511245 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with an acutely ruptured intracranial aneurysm requiring endovascular treatment.
✕Probably not a fit
Patients with aneurysms larger than 10mm or those not located in specified arterial regions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the efficacy and safety of the WEB device against other endovascular techniques for treating acutely ruptured intracranial aneurysms. Patients over 18 years old with specific aneurysm characteristics will be randomly assigned to receive either treatment. The study will assess outcomes related to the management of subarachnoid hemorrhage caused by the aneurysm. The goal is to determine which treatment provides better results for patients.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with ruptured aneurysms.
How similar studies have gone: While there have been studies on endovascular treatments for aneurysms, this specific comparison of WEB versus other techniques is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Main Inclusion Criteria: * Patient is above 18 years of age at the time of consent * Patient has an identified acutely ruptured intracranial aneurysm requiring endovascular treatment (for the purposes of this study an acutely ruptured IA patient is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 30 days) * Aneurysm dome diameter must be ≤ 10mm and within the diameter (and parent vessel diameter, as appropriate) range treatable by commercially available WEB devices as well as at least one other alternative commercially available endovascular treatment device used per hospital standard practice * Aneurysm is located on the anterior communicating artery complex segment (ACom), internal carotid artery terminus (ICAt), anterior cerebral artery (ACA), middle cerebral artery (MCA), basilar apex, posterior communicating artery (PCom) or pericallosal artery * Patient must be neurologically stable with a Hunt \& Hess score of I to III * Patient or patient's legally authorized representative (LAR) has provided written informed consent Main Exclusion Criteria: * Aneurysm to be treated is unsuitable for endovascular treatment with commercially available WEB devices and/or all other available endovascular treatment techniques used per standard site practice * Patient presenting as target aneurysm a blister like or dissecting aneurysm * Patient has more than one aneurysm requiring treatment within 30 days of completion of treatment of the target aneurysm * Patient with multiple aneurysms in whom ruptured aneurysm cannot be identified * Patient has pre-morbid mRS \> 2
Where it's running
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CHU Reims
Reims, France Recruiting
Study contacts
- Study coordinator: Clinical Department
- Email: MVEClinicalEMEA@microvention.com
- Phone: +33(0)139217746
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Evaluating the long-term safety and effectiveness of the WEB device for treating wide neck bifurcation intracranial aneurysms
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.