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Completed

NCT Number: NCT01778322

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

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracranial aneurysm embolization

Procedure

Treatment of intracranial aneurysms

Primary outcomes

  1. Durability of occlusion

    Time frame: 6 months

    Evaluated by the Corelab

Secondary outcomes

  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 outcomes

  1. Fluoroscopy time

    Time frame: procedure

    Duration of fluoroscopy time will be recorded during the procedure

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Acronym: WEBCAST

Important dates

Study start
2011
Primary completion
2015
Study completion
2019
First posted
Jan 29, 2013
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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