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

December 13, 2024 updated by: Microvention-Terumo, Inc.

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

Comparison of efficacy and safety between WEB and other endovascular techniques

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Reims, France
        • Recruiting
        • CHU Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: WEB
Other: Randomisation
Technique assigned through randomization
Other: Other endovascular techniques
Other: Randomisation
Technique assigned through randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months (-3/+6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microvention-Terumo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP EMEA 23-01 (Other Identifier: Sponsor ID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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