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The WEB-IT Clinical Study (WEB-IT)

Primary Purpose

Wide Neck Bifurcation Intracranial Aneurysms, Intracranial Aneurysms

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WEB
Sponsored by
Microvention-Terumo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wide Neck Bifurcation Intracranial Aneurysms focused on measuring Aneurysm, Intracranial Aneurysm, Vascular Diseases, Cardiovascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Neurological Institute
  • Sequent Medical
  • Radiology Imaging Associates P.C.
  • Lyerly Baptist, Inc
  • Rush University Medical Center
  • University of Louisville
  • Johns Hopkins Hospital
  • Brigham and Women's Hospital
  • Tufts Medical Center
  • Abbott Northwestern Hospital
  • Mayo Clinic
  • Albany Medical Center
  • Buffalo General Medical Center
  • The Mount Sinai Medical Center
  • Stony Brook University
  • Carolina NeuroSurgery & Spine Associates, P.A.
  • Riverside Methodist Hospital/ Ohio Health Research Institute
  • Thomas Jefferson University Hospital
  • Medical University of South Carolina (MUSC)
  • Ft. Sanders Regional Medical Center
  • Methodist University Hospital
  • Baptist Memorial Hospital
  • Baylor College of Medicine
  • University of Texas Health Science Center at Houston
  • University of Utah Medical Center
  • West Virginia University
  • Royal University Hospital
  • Rigshospitalet
  • Helios Hospital
  • National Institute of Neurosciences
  • Koru Hospital
  • Marmara University Faculty of Medicine Pendik Training and Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

WEB Aneurysm Embolization Device

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2014
Last Updated
April 13, 2021
Sponsor
Microvention-Terumo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02191618
Brief Title
The WEB-IT Clinical Study
Acronym
WEB-IT
Official Title
The WEB® Intrasaccular Therapy Study (WEB-IT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microvention-Terumo, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wide Neck Bifurcation Intracranial Aneurysms, Intracranial Aneurysms
Keywords
Aneurysm, Intracranial Aneurysm, Vascular Diseases, Cardiovascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WEB Aneurysm Embolization Device
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
WEB
Other Intervention Name(s)
WEB Aneurysm Embolization Device
Intervention Description
The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 months
Title
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
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Arthur, MD
Organizational Affiliation
Methodist University Hospital, Memphis, TN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Fiorella, MD
Organizational Affiliation
Stony Brook University, Stony Brook, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Sequent Medical
City
Aliso Viejo
State/Province
California
ZIP/Postal Code
92565
Country
United States
Facility Name
Radiology Imaging Associates P.C.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Lyerly Baptist, Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021115
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Buffalo General Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
The Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Carolina NeuroSurgery & Spine Associates, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Riverside Methodist Hospital/ Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Ft. Sanders Regional Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Helios Hospital
City
Erfurt
ZIP/Postal Code
99028
Country
Germany
Facility Name
National Institute of Neurosciences
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Koru Hospital
City
Ankara
Country
Turkey
Facility Name
Marmara University Faculty of Medicine Pendik Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
30992395
Citation
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.
Results Reference
derived
PubMed Identifier
28096478
Citation
Fiorella 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.
Results Reference
derived

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The WEB-IT Clinical Study

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