Wide Neck Bifurcation Intracranial AneurysmsWEB-IT ChinaNCT03207087
The WEB®-IT China Clinical Study
A study testing WEB Aneurysm Embolization in people with Wide Neck Bifurcation Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 8 sites in China.
Trial summary
This trial is a prospective, multicenter, single-arm confirmatory clinical trial. The study is to confirm the safety and effectiveness of the WEB Aneurysm Embolization System demonstrated in the US WEB-IT Study for the treatment of intracranial wide-neck bifurcation aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Wide Neck Bifurcation Intracranial Aneurysms
- What is being tested?
- WEB Aneurysm Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesChina
- Study dates
- 21 Jun 2017to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 old
- Patient must have a single ruptured or unruptured IA(intracranial aneurysm)requiring treatment
- Patient must sign and date IRB/EC approved written informed consent prior to initiate 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
8 sites in 1 country.
8 sites in 1 country
China8 sites
Tiantan Hospital
Beijing
Xuanwu Hospital, Capital Medical University
Beijing
West China
Chengdu, Sichuan
The Second affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Changhai Hospital Affiliated to The Second Military Medical University ( Shanghai Changhai Hospital)
Shanghai, Shanghai Municipality
Huashan Hospital
Shanghai
The General Hospital of Shenyang Military
Shenyang
Tangdu Hospital, the Fourth Military Medical University
Xi'an
About this study
Official title: WEB® Intrasaccular Therapy Study China Clinical Trial Protocol
This trial is a prospective, multicenter, single-arm confirmatory clinical trial. The study is to confirm the safety and effectiveness of the WEB Aneurysm Embolization System demonstrated in the US WEB-IT Study for the treatment of intracranial wide-neck bifurcation aneurysms. The study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by an independent third party core lab.
- Being tested
- WEB Aneurysm Embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEB Aneurysm EmbolizationDevice
Subjects will be screened for study eligibility after giving informed consent. The WEB embolization procedure will be performed in the catheterization room using standard angiographic techniques.
| Study group | Role | What they receive |
|---|---|---|
| WEB Aneurysm Embolization Device | Experimental | 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. Subjects will be screened for study eligibility after giving informed consent. Receives: Device: WEB Aneurysm Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis
Proportion of complete (angiographic) aneurysm occlusion as assessed by Core Lab without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment.
Measured: 12 month
Primary Safety Endpoint: Proportion of death and major stroke
Proportion of 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) 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 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start21 Jun 2017
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207087
- Sponsor's protocol ID
- CP-16-001
- Acronym
- WEB-IT China
- Status last verified
- Oct 2020
- First submitted
- 26 Jun 2017
- Last updated
- 23 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
He C, Xu J, Gao X, Li G, Liang G, Jun Y, Zhao Z, Fang B, Xie X, Liu A, Zhang J, Zhang H, Liu J. Woven EndoBridge intrasaccular therapy for the treatment of unruptured wide-necked bifurcation aneurysms: a prospective study in a Chinese population. Chin Neurosurg J. 2026 Jan 20;12(1):2. doi: 10.1186/s41016-025-00418-2.
PubMed 41559830
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEB® Intrasaccular Therapy Study China Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT03207087
- Acronym / sponsor ID
- WEB-IT China / CP-16-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 2 Jul 2017 (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.
This trial is a prospective, multicenter, single-arm confirmatory clinical trial. The study is to confirm the safety and effectiveness of the WEB Aneurysm Embolization System demonstrated in the US WEB-IT Study for the treatment of intracranial wide-neck bifurcation aneurysms. The study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by an independent third party core lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| WEB Aneurysm Embolization Device | Experimental | Device: WEB Aneurysm EmbolizationThe 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. Subjects will be screened for study eligibility after giving informed consent. |
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 old
- Patient must have a single ruptured or unruptured IA(intracranial aneurysm)requiring treatment
- Patient must sign and date IRB/EC approved written informed consent prior to initiate 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 |
|---|---|---|
| WEB Aneurysm EmbolizationSubjects will be screened for study eligibility after giving informed consent. The WEB embolization procedure will be performed in the catheterization room using standard angiographic techniques. | Device | WEB Aneurysm Embolization Device |
Primary outcome
Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis
Time frame: 12 month
Proportion of complete (angiographic) aneurysm occlusion as assessed by Core Lab without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment.
Primary Safety Endpoint: Proportion of death and major stroke
Time frame: 12 month
Proportion of 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) 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 41559830He C, Xu J, Gao X, Li G, Liang G, Jun Y, Zhao Z, Fang B, Xie X, Liu A, Zhang J, Zhang H, Liu J. Woven EndoBridge intrasaccular therapy for the treatment of unruptured wide-necked bifurcation aneurysms: a prospective study in a Chinese population. Chin Neurosurg J. 2026 Jan 20;12(1):2. doi: 10.1186/s41016-025-00418-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WEB Aneurysm Embolization in people with Wide Neck Bifurcation Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 8 sites in China.
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: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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?
Results are not available in the source record.
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?
Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis (time frame: 12 month). 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 NCT03207087, which also lists 1 linked publication.
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 23 Oct 2020.