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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 : 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):
Sequent Medical, Inc

Tracking Information
First Submitted Date  ICMJE July 14, 2014
First Posted Date  ICMJE July 16, 2014
Results First Submitted Date  ICMJE February 18, 2020
Results First Posted Date  ICMJE April 14, 2020
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
Primary Safety Outcome [ Time Frame: 12 months ]
The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The WEB-IT Clinical Study
Official Title  ICMJE The WEB® Intrasaccular Therapy Study (WEB-IT)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Wide Neck Bifurcation Intracranial Aneurysms
  • Intracranial Aneurysms
Intervention  ICMJE Device: WEB
The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
Other Name: WEB Aneurysm Embolization Device
Study Arms  ICMJE 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.

Intervention: Device: WEB
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
150
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2014)
139
Estimated Study Completion Date  ICMJE June 2021
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Germany,   Hungary,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02191618
Other Study ID Numbers  ICMJE CP13-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sequent Medical, Inc
Study Sponsor  ICMJE Sequent Medical, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adam Arthur, MD Methodist University Hospital, Memphis, TN
Principal Investigator: David Fiorella, MD Stony Brook University, Stony Brook, NY
PRS Account Sequent Medical, Inc
Verification Date April 2020

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