Wide Neck Bifurcation Intracranial AneurysmsWEB PASNCT04839705
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
A study testing WEB in people with Wide Neck Bifurcation Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 27 sites in United States.
Trial summary
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wide Neck Bifurcation 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
- 195 participants
- Where
- 27 sitesUnited States
- Study dates
- 24 Aug 2022to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be ≥ 18 at the time of screening
- Patient must have a single ruptured or unruptured IA requiring treatment
- Patient must sign and date an IRN 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 conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
- Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
- Patient index IA was previously treated
- Patient is pregnant
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Albany Medical Center
Albany, New York, 12208
Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Brigham Incorporated
Boston, Massachusetts, 02114
University of Buffalo
Buffalo, New York, 14203
Ohio State University
Columbus, Ohio, 43210
OhioHealth Research Institute
Columbus, Ohio, 43214
Memorial Health Systems
Hollywood, Florida, 33021
The Queen's Medical Center Neuroscience Institute
Honolulu, Hawaii, 96813
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kansas Health System
Kansas City, Kansas, 66160
Baptist Health Systems
Lexington, Kentucky, 40503
University of Kentucky, Department of Neurosurgery
Lexington, Kentucky, 40536
Norton Healthcare
Louisville, Kentucky, 40241
Northshore University Hospital/Northwell Health
Manhasset, New York, 11030
Semmes Murphey
Memphis, Tennessee, 38120
Abbott Northwestern Hospital Allina Health
Minneapolis, Minnesota, 55407
West Virginia University
Morgantown, West Virginia, 26506
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Orlando Health Neuroscience Institute
Orlando, Florida, 32806
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
The Washington University
St Louis, Missouri, 63110
SUNY Stony Brook
Stony Brook, New York, 11794
Montefiore Medical Center
The Bronx, New York, 10467
The Toledo Hospital d/b/a ProMedica Toledo Hospital
Toledo, Ohio, 43606
UMass Memorial Health
Worcester, Massachusetts, 01655
About this study
Official title: Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
- Being tested
- WEB
- Keywords
- Aneurysm, Intracranial Arterial Disease, Cerebrovascular Disorders
- Medical subject headings
- Aneurysm, Intracranial Arterial Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEBDevice
Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
Other Names:
- WEB Aneurysm Embolization Device
| Study group | Role | What they receive |
|---|---|---|
| WEB Aneurysm Embolization Device | Other | 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. Receives: Device: WEB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key Effectiveness Outcome
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Measured: 12 Months
Key Safety Outcome
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
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 posted9 Apr 2021
- Study start24 Aug 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Fiorella, MD, Principal investigator, Stony Brook University, Stony Brook NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839705
- Sponsor's protocol ID
- CL11010-001
- Acronym
- WEB PAS
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
- ClinicalTrials.gov ID
- NCT04839705
- Acronym / sponsor ID
- WEB PAS / CL11010-001
- Keywords
- Aneurysm, Intracranial Arterial Disease, Cerebrovascular Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate 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: WEBWEB 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must be ≥ 18 at the time of screening
- Patient must have a single ruptured or unruptured IA requiring treatment
- Patient must sign and date an IRN 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 conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
- Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
- Patient 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 |
|---|---|---|
| WEBDevice: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. Other Names: • WEB Aneurysm Embolization Device | Device | WEB Aneurysm Embolization Device |
Primary outcome
Key Effectiveness Outcome
Time frame: 12 Months
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Key Safety Outcome
Time frame: 12 Months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Recruiting
Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)
Unruptured Intracranial Wide-neck Bifurcation Aneurysms
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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.
David Fiorella, MD principal investigator
Stony Brook University, Stony Brook NY
27 sites in 1 country: 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, run by Microvention-Terumo, Inc. at 27 sites in United States.
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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Key Effectiveness Outcome (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?
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 Mar 2026.