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

MicroVention

Status: Enrolling

Conditions: Ruptured Aneurysm

Treatments: Other: Randomisation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06511245

CIP EMEA 23-01 (Other Identifier)

Details and patient eligibility

About

Comparison of efficacy and safety between WEB and other endovascular techniques

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

WEB

Other group

Treatment:

Other: Randomisation

Other endovascular techniques

Other group

Treatment:

Other: Randomisation