WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

Completed

• Conditions: Intracranial Aneurysm
• Interventions: Procedure: Intracranial aneurysm embolization

• Registration Number: NCT01778322
• Lead Sponsor: Microvention-Terumo, Inc.

Brief Summary

The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

Detailed Description

The following parameters will be evaluated as part of this study:

* Aneurysm morphology

* Aneurysm size

* For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH)

* Size of the embolization device(s) used in the procedure

* Intra-procedural assessment of aneurysm occlusion and flow stasis

* Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate)

* Aneurysm occlusion durability

* Recanalization rate

* Device-related changes in Modified Rankin Scale from baseline

* Complications/adverse events

* Rebleed/new bleed

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-29
• Primary Completion: 2015-12
• Study Completion: 2019-12
• Status Verified: 2022-08
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Must be at least 18 years of age
• Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures

Exclusion Criteria

• Must not have clinical or angiographic evidence of vasospasm
• Must not have lesion with characteristics unsuitable for endovascular treatment
• Must not have neurologic or psychiatric conditions, which preclude ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
• Must not be concurrently involved in another investigational or post-market study
• Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Index Embolization Cohort	Intracranial aneurysm embolization	WEB Aneurysm Embolization System

Primary Outcome Measures

Name	Time	Method
Durability of occlusion	6 months	Evaluated by the Corelab

Secondary Outcome Measures

Name	Time	Method
Percentage occlusion of target aneurysm	6 months	Evaluated by the Corelab
Recurrence/recanalization rate	6 months	Evaluated by the Corelab, based on Raymond Roy occlusion scale
Modified Raymond Scale	6 months	Evaluation of patient's functional level of activity by the physician

Trial Locations

Locations (12)

Klinikum der Johann Wolfgang Goethe Universität; 🇩🇪 Frankfurt, Germany

Hôpital Beaujon; 🇫🇷 Clichy, France

Klinikum Vest GmbH; 🇩🇪 Recklinghausen, Germany

CHU Gui de Chauliac; 🇫🇷 Montpellier, France

CHU Reims Maison Blanche; 🇫🇷 Reims, France

CHU Bretonneau; 🇫🇷 Tours, France

National Institute of Neurosciences; 🇭🇺 Budapest, Hungary

Helios Klinikum; 🇩🇪 Erfurt, Germany

Uniklinik Koeln; 🇩🇪 Cologne, Germany

Klinikum Stuttgart- Katharinenhospital; 🇩🇪 Stuttgart, Germany

CHU Purpan; 🇫🇷 Toulouse, France

Rigshospitalet; 🇩🇰 Copenhagen, Denmark