Wide Neck Bifurcation Intracranial AneurysmsWEB-ITNCT02191618
The WEB-IT Clinical Study
A study testing WEB in people with Wide Neck Bifurcation Intracranial Aneurysms and Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 32 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Wide Neck Bifurcation Intracranial Aneurysms, Intracranial Aneurysms
- What is being tested?
- WEB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 32 sitesin 6 countries
- Study dates
- Aug 2014to Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
United States26 sites
Albany Medical Center
Albany, New York, 12208
Sequent Medical
Aliso Viejo, California, 92565
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 021115
Tufts Medical Center
Boston, Massachusetts, 02111
Buffalo General Medical Center
Buffalo, New York, 14203
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Carolina NeuroSurgery & Spine Associates, P.A.
Charlotte, North Carolina, 28204
Rush University Medical Center
Chicago, Illinois, 60612
Riverside Methodist Hospital/ Ohio Health Research Institute
Columbus, Ohio, 43214
Radiology Imaging Associates P.C.
Englewood, Colorado, 80112
Baylor College of Medicine
Houston, Texas, 77030
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Lyerly Baptist, Inc
Jacksonville, Florida, 32207
Ft. Sanders Regional Medical Center
Knoxville, Tennessee, 37916
University of Louisville
Louisville, Kentucky, 40202
Methodist University Hospital
Memphis, Tennessee, 38104
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
West Virginia University
Morgantown, West Virginia, 26505
The Mount Sinai Medical Center
New York, New York, 10029
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah Medical Center
Salt Lake City, Utah, 84132
Stony Brook University
Stony Brook, New York, 11794
Turkey (Türkiye)2 sites
Koru Hospital
Ankara
Marmara University Faculty of Medicine Pendik Training and Research Hospital
Istanbul
About this study
Official title: The WEB® Intrasaccular Therapy Study (WEB-IT)
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.
- Being tested
- WEB
- Keywords
- Aneurysm, Intracranial Aneurysm, Vascular Diseases, Cardiovascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Medical subject headings
- Intracranial Aneurysm, Aneurysm, Vascular Diseases, Cardiovascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEBDevice
Also called WEB Aneurysm Embolization Device
The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
| Study group | Role | What they receive |
|---|---|---|
| WEB Aneurysm Embolization Device | Other | 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. Receives: Device: WEB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2017
- Study completionJun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wide Neck Bifurcation Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Arthur, MD, Principal investigator, Methodist University Hospital, Memphis, TNDavid Fiorella, MD, Principal investigator, Stony Brook University, Stony Brook, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191618
- Sponsor's protocol ID
- CP13-001
- Acronym
- WEB-IT
- Status last verified
- Apr 2020
- First submitted
- 14 Jul 2014
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30992395Fiorella 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.
PubMed 28096478
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WEB® Intrasaccular Therapy Study (WEB-IT)
- ClinicalTrials.gov ID
- NCT02191618
- Acronym / sponsor ID
- WEB-IT / CP13-001
- Keywords
- Aneurysm, Intracranial Aneurysm, Vascular Diseases, Cardiovascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WEB Aneurysm Embolization Device | Other | Device: WEBThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WEBAlso: WEB Aneurysm Embolization DeviceThe WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. | Device | WEB Aneurysm Embolization Device |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30992395Arthur 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.
- Derived from this study: PubMed 28096478Fiorella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Arthur, MD principal investigator
Methodist University Hospital, Memphis, TN
David Fiorella, MD principal investigator
Stony Brook University, Stony Brook, NY
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WEB in people with Wide Neck Bifurcation Intracranial Aneurysms and Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 32 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Turkey (Türkiye), Canada, Denmark, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02191618, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.