The WEB-IT Clinical Study
WEB-IT
The WEB® Intrasaccular Therapy Study (WEB-IT)
1 other identifier
interventional
150
6 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedResults Posted
Study results publicly available
April 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedDecember 27, 2024
April 1, 2020
3.1 years
July 14, 2014
February 18, 2020
December 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
12 months
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
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.
12 months
Study Arms (1)
WEB Aneurysm Embolization Device
OTHERThe 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.
Interventions
The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Sequent Medical
Aliso Viejo, California, 92565, United States
Radiology Imaging Associates P.C.
Englewood, Colorado, 80112, United States
Lyerly Baptist, Inc
Jacksonville, Florida, 32207, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Brigham and Women's Hospital
Boston, Massachusetts, 021115, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Albany Medical Center
Albany, New York, 12208, United States
Buffalo General Medical Center
Buffalo, New York, 14203, United States
The Mount Sinai Medical Center
New York, New York, 10029, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Carolina NeuroSurgery & Spine Associates, P.A.
Charlotte, North Carolina, 28204, United States
Riverside Methodist Hospital/ Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Ft. Sanders Regional Medical Center
Knoxville, Tennessee, 37916, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Utah Medical Center
Salt Lake City, Utah, 84132, United States
West Virginia University
Morgantown, West Virginia, 26505, United States
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Rigshospitalet
Copenhagen, 2100, Denmark
Helios Hospital
Erfurt, 99028, Germany
National Institute of Neurosciences
Budapest, 1145, Hungary
Koru Hospital
Ankara, Turkey (Türkiye)
Marmara University Faculty of Medicine Pendik Training and Research Hospital
Istanbul, Turkey (Türkiye)
Related Publications (2)
Arthur AS, Molyneux A, Coon AL, Saatci I, Szikora I, Baltacioglu F, Sultan A, Hoit D, Delgado Almandoz JE, Elijovich L, Cekirge S, Byrne JV, Fiorella D; WEB-IT Study investigators. The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study. J Neurointerv Surg. 2019 Sep;11(9):924-930. doi: 10.1136/neurintsurg-2019-014815. Epub 2019 Apr 16.
PMID: 30992395DERIVEDFiorella D, Molyneux A, Coon A, Szikora I, Saatci I, Baltacioglu F, Sultan A, Arthur A; WEB-IT Study Investigators. Demographic, procedural and 30-day safety results from the WEB Intra-saccular Therapy Study (WEB-IT). J Neurointerv Surg. 2017 Dec;9(12):1191-1196. doi: 10.1136/neurintsurg-2016-012841. Epub 2017 Jan 17.
PMID: 28096478DERIVED
MeSH Terms
Conditions
Results Point of Contact
- Title
- Director, Clinical Operations
- Organization
- Sequent Medical, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Arthur, MD
Methodist University Hospital, Memphis, TN
- PRINCIPAL INVESTIGATOR
David Fiorella, MD
Stony Brook University, Stony Brook, NY
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2014
First Posted
July 16, 2014
Study Start
August 1, 2014
Primary Completion
September 1, 2017
Study Completion
June 1, 2023
Last Updated
December 27, 2024
Results First Posted
April 14, 2020
Record last verified: 2020-04