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WEB Clinical Assessment of IntraSaccular Aneurysm Therapy (WEBCAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01778322
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

Study Description
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Brief Summary:
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

Condition or disease Intervention/treatment
Intracranial Aneurysm Procedure: Intracranial aneurysm embolization

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 Design
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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
Study Start Date : December 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Index Embolization Cohort
WEB Aneurysm Embolization System
 Procedure: Intracranial aneurysm embolization
Treatment of intracranial aneurysms


Outcome Measures
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Primary Outcome Measures :
  1. Durability of occlusion [ Time Frame: 6 months ]
    Evaluated by the Corelab


Secondary Outcome Measures :
  1. Recurrence/recanalization rate [ Time Frame: 6 months ]
    Evaluated by the Corelab, based on Raymond Roy occlusion scale

  2. Modified Raymond Scale [ Time Frame: 6 months ]
    Evaluation of patient's functional level of activity by the physician

  3. Percentage occlusion of target aneurysm [ Time Frame: 6 months ]
    Evaluated by the Corelab


Other Outcome Measures:
  1. Fluoroscopy time [ Time Frame: procedure ]
    Duration of fluoroscopy time will be recorded during the procedure


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778322


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
France
Hôpital Beaujon
Clichy, France, 92118
CHU Gui de Chauliac
Montpellier, France, 34295
CHU Reims Maison Blanche
Reims, France, 51092
CHU Purpan
Toulouse, France, 31059
CHU Bretonneau
Tours, France, 37000
Germany
Uniklinik Koeln
Cologne, Germany, 50937
Helios Klinikum
Erfurt, Germany, 99089
Klinikum der Johann Wolfgang Goethe Universität
Frankfurt, Germany, 60528
Klinikum Vest GmbH
Recklinghausen, Germany, 45657
Klinikum Stuttgart- Katharinenhospital
Stuttgart, Germany, 70174
Hungary
National Institute of Neurosciences
Budapest, Hungary, H-1145
Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
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Principal Investigator: Laurent Pierot, MD CHU Reims
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT01778322    
Other Study ID Numbers: CP 11-001
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: August 2022
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases