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
  Purpose

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


Condition Intervention
Intracranial Aneurysm
Procedure: Intracranial aneurysm embolization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

Resource links provided by NLM:


Further study details as provided by Sequent Medical, Inc:

Primary Outcome Measures:
  • Durability of occlusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Fluoroscopy time [ Time Frame: procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Index Embolization Cohort
WEB Aneurysm Embolization System
Procedure: Intracranial aneurysm embolization
Treatment of intracranial aneurysms

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778322

Locations
Belgium
Hôpital Universitaire Erasme
Brussels, Belgium
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
Alfried Krupp Krankenhaus Rüttenscheid
Essen, Germany, 45131
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
Italy
Bellaria Hospital
Bologna, Italy, 40139
Sponsors and Collaborators
Sequent Medical, Inc
Investigators
Principal Investigator: Laurent Pierot, MD CHU Reims
  More Information

No publications provided

Responsible Party: Sequent Medical, Inc
ClinicalTrials.gov Identifier: NCT01778322     History of Changes
Other Study ID Numbers: CP 11-001
Study First Received: January 25, 2013
Last Updated: October 28, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014