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NCT01778322 Clinical Trial

WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

Intracranial Aneurysm Clinical Trial

— WEBCAST  

Official title:
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01778322
Other study ID # CP 11-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2011
Est. completion date December 2019

Study information
Verified date August 2022
Source Microvention-Terumo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date December 2019
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Intracranial aneurysm embolization
Treatment of intracranial aneurysms

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen
France Hôpital Beaujon Clichy
France CHU Gui de Chauliac Montpellier
France CHU Reims Maison Blanche Reims
France CHU Purpan Toulouse
France CHU Bretonneau Tours
Germany Uniklinik Koeln Cologne
Germany Helios Klinikum Erfurt
Germany Klinikum der Johann Wolfgang Goethe Universität Frankfurt
Germany Klinikum Vest GmbH Recklinghausen
Germany Klinikum Stuttgart- Katharinenhospital Stuttgart
Hungary National Institute of Neurosciences Budapest

Sponsors (1)
Lead Sponsor Collaborator
Microvention-Terumo, Inc.

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Other Fluoroscopy time Duration of fluoroscopy time will be recorded during the procedure procedure
Primary Durability of occlusion Evaluated by the Corelab 6 months
Secondary Recurrence/recanalization rate Evaluated by the Corelab, based on Raymond Roy occlusion scale 6 months
Secondary Modified Raymond Scale Evaluation of patient's functional level of activity by the physician 6 months
Secondary Percentage occlusion of target aneurysm Evaluated by the Corelab 6 months
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