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. Identifier: NCT01778322
Recruitment Status : Active, not recruiting
First Posted : January 29, 2013
Last Update Posted : April 17, 2018
Information provided by (Responsible Party):
Sequent Medical, Inc

January 25, 2013
January 29, 2013
April 17, 2018
December 2011
December 2015   (Final data collection date for primary outcome measure)
Durability of occlusion [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01778322 on Archive Site
  • Recurrence/recanalization rate [ Time Frame: 6 months ]
  • Modified Raymond Scale [ Time Frame: 6 months ]
  • Percentage occlusion of target aneurysm [ Time Frame: 6 months ]
Not Provided
Fluoroscopy time [ Time Frame: procedure ]
Not Provided
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Subjects with:

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

Intracranial Aneurysm
Procedure: Intracranial aneurysm embolization
Treatment of intracranial aneurysms
Index Embolization Cohort
WEB Aneurysm Embolization System
Intervention: Procedure: Intracranial aneurysm embolization
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
June 2020
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Germany,   Hungary
Belgium,   Italy
CP 11-001
Not Provided
Not Provided
Sequent Medical, Inc
Sequent Medical, Inc
Not Provided
Principal Investigator: Laurent Pierot, MD CHU Reims
Sequent Medical, Inc
April 2018