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Recruiting

NCT Number: NCT06511245

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

Comparison of efficacy and safety between WEB and other endovascular techniques

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Reims

Reims, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Randomisation

Other

Technique assigned through randomization

Primary outcomes

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Department

CONTACT

[email protected]

+33(0)139217746

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Official study title

WEB™ Embolization System in the Treatment of Acutely Ruptured Intracranial Aneurysms Versus Other Endovascular Techniques

Acronym: WAVE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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