Intracranial AneurysmsNCT07022249
Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms
A study testing Intrasaccular Embolization Device in people with Intracranial Aneurysms, run by Ton-Bridge Medical Tech. Co., Ltd.
Trial summary
The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- Intrasaccular Embolization Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jun 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be 18-75 years of age at the time of screening.
- Patient must have a single ruptured or unruptured IA requiring treatment.
- Patient was able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule, signed and dated an written informed consent prior to initiation of any study procedures.
Who cannot join
- Patient had an IA with characteristics unsuitable for endovascular treatment.
- Patient had vessel characteristics, tortuosity or morphology which precluded safe access and support during treatment with study device.
- Patient had vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
- Patient had vasculitis, an intracranial tumor (except benign tumors that do not require treatment) or any other intracranial vascular malformations on presentation.
- Patient was taking anticoagulants or had a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
- Patient was pregnant.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms : a Prospective, Multicenter, Single-arm Trial
The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.
- Conditions
- Intracranial Aneurysms
- Being tested
- Intrasaccular Embolization Device
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrasaccular Embolization DeviceDevice
This is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.The intended therapeutic effect of this 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Intrasaccular Embolization Device Receives: Device: Intrasaccular Embolization Device |
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.
Measured: 12 months
Percentage of Subjects With Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One 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 posted15 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Ton-Bridge Medical Tech. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022249
- Sponsor's protocol ID
- ZHTQ202501
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms : a Prospective, Multicenter, Single-arm Trial
- ClinicalTrials.gov ID
- NCT07022249
- Acronym / sponsor ID
- ZHTQ202501
- Conditions
- Intracranial Aneurysms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ton-Bridge Medical Tech. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Jun 2025 (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.
The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Intrasaccular Embolization DeviceIntrasaccular Embolization Device |
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 must be 18-75 years of age at the time of screening.
- Patient must have a single ruptured or unruptured IA requiring treatment.
- Patient was able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule, signed and dated an written informed consent prior to initiation of any study procedures.
Key exclusion criteria (6 listed)
- Patient had an IA with characteristics unsuitable for endovascular treatment.
- Patient had vessel characteristics, tortuosity or morphology which precluded safe access and support during treatment with study device.
- Patient had vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
- Patient had vasculitis, an intracranial tumor (except benign tumors that do not require treatment) or any other intracranial vascular malformations on presentation.
- Patient was taking anticoagulants or had a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
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 |
|---|---|---|
| Intrasaccular Embolization DeviceThis is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.The intended therapeutic effect of this 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. | Device | Experimental Group |
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
Percentage of Subjects With Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment.
Time frame: 12 months
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 15 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intrasaccular Embolization Device in people with Intracranial Aneurysms, run by Ton-Bridge Medical Tech. Co., Ltd.
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 6 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: opening soon, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Xiaoyan Yang (18577072001, xy.yang@ton-bridge.com), or a site near the patient. 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?
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 15 Jun 2025.