WEB Clinical Assessment of IntraSaccular Aneurysm Therapy (WEBCAST)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sequent Medical, Inc
ClinicalTrials.gov Identifier:
NCT01778322
First received: January 25, 2013
Last updated: October 28, 2013
Last verified: October 2013

January 25, 2013
October 28, 2013
December 2011
December 2013   (final data collection date for primary outcome measure)
Durability of occlusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01778322 on ClinicalTrials.gov Archive Site
  • Recurrence/recanalization rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Modified Raymond Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage occlusion of target aneurysm [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Fluoroscopy time [ Time Frame: procedure ] [ Designated as safety issue: No ]
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
December 2018
December 2013   (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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   France,   Germany,   Hungary,   Italy
 
NCT01778322
CP 11-001
No
Sequent Medical, Inc
Sequent Medical, Inc
Not Provided
Principal Investigator: Laurent Pierot, MD CHU Reims
Sequent Medical, Inc
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP