CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.

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Key information

Conditions

Brain Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Bicêtre, Le Kremlin-Bicêtre, France

About this study

All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.

Subjects will be followed per Institution's standard of care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subject must be ≥ 18 years of age and ≤80 years of age
Subject must have an intracranial aneurysm (IA),
Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection
For ruptured aneurysm, Subject with Hunt & Hess Score ≤ III

Exclusion criteria

Subject has an IA with characteristics unsuitable for endovascular treatment
Subject's index IA was previously treated
Subject has stroke-in-evolution within the prior 30 days
An additional aneurysm must be treated during the procedure

Treatment and study plan

WEB Aneurysm Embolization System

Device

Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms.

Primary outcomes

Aneurysm occlusion

Time frame: 12 months
Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms.
- class I: complete obliteration
- class II: residual neck
- class III: residual aneurysm
Incidence of major stroke or neurological deaths

Time frame: 12months

The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Official study title

CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

Acronym: CLEVER

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Feb 18, 2019
Registry last updated: Jan 24, 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.

Published trials that share one or more normalized conditions with this study.

Completed