Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach

4 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 years study duration

Study Start

First participant enrolled

December 1, 2011

Completed

1.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed

4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed

Last Updated

March 15, 2023

Status Verified

August 1, 2022

Enrollment Period

4 years

First QC Date

January 25, 2013

Last Update Submit

March 13, 2023

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

Durability of occlusion
Evaluated by the Corelab
6 months

Secondary Outcomes (3)

Recurrence/recanalization rate
6 months
Modified Raymond Scale
6 months
Percentage occlusion of target aneurysm
6 months

Other Outcomes (1)

Fluoroscopy time
procedure

Study Arms (1)

Index Embolization Cohort

WEB Aneurysm Embolization System

Procedure: Intracranial aneurysm embolization

Interventions

Intracranial aneurysm embolizationPROCEDURE

Treatment of intracranial aneurysms

Index Embolization Cohort

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Subjects with: \- Diameter and width of the aneurysm is appropriate size for treatment with the WEB Aneurysm Embolization System per device Instructions for Use

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Microvention-Terumo, Inc.lead

Study Sites (12)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hôpital Beaujon

Clichy, 92118, France

Location

CHU Gui de Chauliac

Montpellier, 34295, France

Location

CHU Reims Maison Blanche

Reims, 51092, France

Location

CHU Purpan

Toulouse, 31059, France

Location

CHU Bretonneau

Tours, 37000, France

Location

Uniklinik Koeln

Cologne, 50937, Germany

Location

Helios Klinikum

Erfurt, 99089, Germany

Location

Klinikum der Johann Wolfgang Goethe Universität

Frankfurt, 60528, Germany

Location

Klinikum Vest GmbH

Recklinghausen, 45657, Germany

Location

Klinikum Stuttgart- Katharinenhospital

Stuttgart, 70174, Germany

Location

National Institute of Neurosciences

Budapest, H-1145, Hungary

Location

Related Publications (4)

Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Klisch J, Herbreteau D, Costalat V, Fiehler J, Januel AC, Liebig T, Stockx L, Weber W, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up. J Neurointerv Surg. 2023 Jun;15(6):552-557. doi: 10.1136/neurintsurg-2021-018414. Epub 2022 Jul 8.
PMID: 35803731DERIVED
Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Herbreteau D, Fiehler J, Costalat V, Klisch J, Januel AC, Weber W, Liebig T, Stockx L, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up. J Neurointerv Surg. 2021 Apr;13(4):363-368. doi: 10.1136/neurintsurg-2020-016151. Epub 2020 Jun 12.
PMID: 32532858DERIVED
Pierot L, Moret J, Barreau X, Szikora I, Herbreteau D, Turjman F, Holtmannspotter M, Januel AC, Costalat V, Fiehler J, Klisch J, Gauvrit JY, Weber W, Desal H, Velasco S, Liebig T, Stockx L, Berkefeld J, Molyneux A, Byrne J, Spelle L. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series. J Neurointerv Surg. 2018 Jun;10(6):553-559. doi: 10.1136/neurintsurg-2017-013448. Epub 2017 Sep 30.
PMID: 28965106DERIVED
Pierot L, Spelle L, Molyneux A, Byrne J; WEBCAST and French Observatory Investigators. Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). Neurosurgery. 2016 Jan;78(1):133-41. doi: 10.1227/NEU.0000000000001106.
PMID: 26552042DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

Laurent Pierot, MD
CHU REIMS
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

December 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2019

Last Updated

March 15, 2023

Record last verified: 2022-08

Locations

DK(1)HU(1)DE(5)FR(5)

WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (1)

Index Embolization Cohort

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (1)

Index Embolization Cohort

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations