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Trial record 1 of 1 for:    02191618
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The WEB-IT Clinical Study (WEB-IT)

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: NCT02191618
Recruitment Status : Unknown
Verified April 2020 by Microvention-Terumo, Inc..
Recruitment status was:  Active, not recruiting
First Posted : July 16, 2014
Results First Posted : April 14, 2020
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

Study Description
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Brief Summary:
The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Condition or disease Intervention/treatment Phase
Wide Neck Bifurcation Intracranial Aneurysms Intracranial Aneurysms Device: WEB Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The WEB® Intrasaccular Therapy Study (WEB-IT)
Actual Study Start Date : August 2014
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
WEB Aneurysm Embolization Device

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

 Device: WEB
The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
Other Name: WEB Aneurysm Embolization Device


Outcome Measures
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Primary Outcome Measures :
  1. The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365. [ Time Frame: 12 months ]
    The study's primary safety endpoint was the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS)) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 days after treatment.

  2. Percentage of Subjects With Complete Aneurysm Occlusion Assessed Using the WEB Occlusion Scale (WOS) Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment [ Time Frame: 12 months ]
    The primary effectiveness endpoint was defined as the percentage of subjects with complete aneurysm occlusion assessed using the WEB Occlusion Scale (WOS) without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment in the mITT population.


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
Criteria

Inclusion Criteria:

  • Patient whose age ≥18 and ≤75 years.
  • Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment.
  • Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

  • Patient has an IA with characteristics unsuitable for endovascular treatment
  • Patient has stroke-in-evolution within the prior 60 days
  • Patient has had an SAH (subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
  • Patient's index IA was previously treated
  • Patient is pregnant
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): NCT02191618


Locations
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Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
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Principal Investigator: Adam Arthur, MD Methodist University Hospital, Memphis, TN
Principal Investigator: David Fiorella, MD Stony Brook University, Stony Brook, NY
  Study Documents (Full-Text)

Documents provided by Microvention-Terumo, Inc.:
Study Protocol  [PDF] August 12, 2015
Statistical Analysis Plan  [PDF] August 12, 2015

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

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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT02191618    
Other Study ID Numbers: CP13-001
First Posted: July 16, 2014    Key Record Dates
Results First Posted: April 14, 2020
Last Update Posted: May 5, 2021
Last Verified: April 2020
Keywords provided by Microvention-Terumo, Inc.:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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