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RecruitingNCT06511245WAVEUpdated Dec 18, 2024

European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.

An interventional study of Randomisation in Ruptured Aneurysm, sponsored by Microvention-Terumo, Inc.. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Microvention-Terumo, Inc. (part of Terumo Corporation) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Comparison of efficacy and safety between WEB and other endovascular techniques

02

Conditions studied

  • Ruptured Aneurysm

Browse trials for

03

In context

Aneurysm, Ruptured

29 studies on the registry are indexed under Aneurysm, Ruptured; 7 are open to participants now.

This study's planned enrollment of 80 is above the median of 33 across 16 interventional studies indexed under Aneurysm, Ruptured.

Browse Aneurysm, Ruptured studies →

Lead sponsor

Microvention-Terumo, Inc. is the lead sponsor of 32 studies on the registry; 7 are open to participants now.

First submitted after Microvention-Terumo, Inc. became part of Terumo Corporation.

Browse Microvention-Terumo, Inc. studies →All Terumo Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Other
    WEB

    Other: Randomisation

  • Other
    Other endovascular techniques

    Other: Randomisation

Interventions

  • OtherRandomisation

    Technique assigned through randomization

06

What researchers measure

Primary outcomes

  1. As exploratory design, one of the outcome will be the assessment of aneurysm occlusion at 12 months using Raymond-Roy scale.

    Raymond-Roy Classification is an angiographic classification including 3 classes, from class 1 (complete obliteration) to class 3 (aneurysm remnant).

    Time frame: 12 months (-3/+6 months)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2024 (actual). Primary completion is estimated for Jun 2027, 32 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2024
First posted
Jul 19, 2024
StartActual
Oct 2, 2024
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Dec 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06511245
Lead sponsor
Microvention-Terumo, Inc.
Responsible party
Sponsor
First posted
Jul 19, 2024
Start date
Oct 2, 2024
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Dec 18, 2024

Study contacts

Clinical Department
Contact
MVEClinicalEMEA@microvention.com
+33(0)139217746

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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