CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

• Sponsor: Microvention-Terumo, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03844334
• Collaborator: (none)
• Enrollment: 163
• Locations: 4
• Anticipated Duration (Months): 42.4
• Patients Per Site: 40.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain Aneurysm	Device: WEB Aneurysm Embolization System

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 163 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
• Actual Study Start Date: Mar 21, 2019
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Outcome Measures

Primary Outcome Measures

1. Aneurysm occlusion [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

2. Incidence of major stroke or neurological deaths [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Bicêtre	Le Kremlin-Bicêtre		France	94270
2	Hôpital Purpan	Toulouse		France	31059
3	Universitätsklinikum Knappschaftskrankenhaus	Bochum		Germany	44892
4	National Institute of Clinical Neurosciences	Budapest		Hungary	1145

Sponsors and Collaborators

• Microvention-Terumo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Microvention-Terumo, Inc.
• ClinicalTrials.gov Identifier: NCT03844334
• Other Study ID Numbers: CIP EMEA 18-02
• First Posted: Feb 18, 2019
• Last Update Posted: Jul 29, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

No Results Posted as of Jul 29, 2021