CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

Brain Aneurysm Clinical Trial

— CLEVER  

Official title:

CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844334
• Other study ID #: CIP EMEA 18-02
• Status: Completed
• Start date: March 21, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: January 2024
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject must be = 18 years of age and =80 years of age

2. Subject must have an intracranial aneurysm (IA),

3. 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

4. For ruptured aneurysm, Subject with Hunt & Hess Score = III

Exclusion Criteria:

1. Subject has an IA with characteristics unsuitable for endovascular treatment

2. Subject's index IA was previously treated

3. Subject has stroke-in-evolution within the prior 30 days

4. An additional aneurysm must be treated during the procedure

Related Conditions & MeSH terms

• Aneurysm
• Brain Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• WEB Aneurysm Embolization System
Subjects aged = 18 years, but = 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms.

Locations

Country	Name	City	State
France	Hôpital Bicêtre	Le Kremlin-Bicêtre
France	Hôpital Purpan	Toulouse
Germany	Universitätsklinikum Knappschaftskrankenhaus	Bochum
Hungary	National Institute of Clinical Neurosciences	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Countries where clinical trial is conducted

France,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aneurysm occlusion	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	12 months
Primary	Incidence of major stroke or neurological deaths	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	12months

External Links

•   CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms