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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicrovention-Terumo, Inc.

About this trial

Comparison of efficacy and safety between WEB and other endovascular techniques

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Randomisation

    Other intervention

    Technique assigned through randomization

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: WEBOther 1 intervention
Group B: Other endovascular techniquesOther 1 intervention

Trial outcomes

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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