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

NCT06511245 | Recruiting

• 1 other identifier: CIP EMEA 23-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of efficacy and safety between WEB and other endovascular techniques

Conditions

Ruptured Aneurysm

Outcome Measures

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).

  12 months (-3/+6 months)

Study Arms (2)

WEB

OTHER

Other: Randomisation

Other endovascular techniques

OTHER

Other: Randomisation

Interventions

Randomisation OTHER

Technique assigned through randomization

Other endovascular techniques; WEB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (1)

CHU Reims

Reims, France

RECRUITING

MeSH Terms

Conditions

Aneurysm, Ruptured

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Clinical Department

CONTACT

+33(0)139217746; MVEClinicalEMEA@microvention.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 19, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

FR (1)