Intracranial Arteriovenous MalformationsNCT06479343
Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations
A study testing Liquid Embolic System (Tonbridge) and Onyx Liquid Embolic System (Medtronic) in people with Intracranial Arteriovenous Malformations, run by Ton-Bridge Medical Tech. Co., Ltd at 14 sites in China.
Trial summary
The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd. (Suzhou)) for the treatment of cerebrovascular malformations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Arteriovenous Malformations
- What is being tested?
- Liquid Embolic System (Tonbridge) and Onyx Liquid Embolic System (Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 14 sitesChina
- Study dates
- 27 Jun 2024to Oct 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years, any gender;
- Subject is suitable for endovascular treatment of cerebrovascular malformations;
- Subject is able to understand the purpose of the study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
Who cannot join
- Intracranial hemorrhage within 1 month prior to treatment;
- The targeted embolization area needs to receive other treatments (surgical resection, SRS, other embolic materials) at the same time;
- Combination of other cerebrovascular malformations, such as cavernous vascular malformation;
- Severe stenosis or occlusion of cerebral feeding artery requiring surgical intervention;
- Intracranial tumor requiring surgical intervention;
- mRS score≥3;
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- Heart, lung, liver and renal failure or other severe diseases;
- Known bleeding tendency, such as coagulation dysfunction (INR>1.5);
- Known allergy to DMSO and contrast media, or contraindication to anticoagulant therapy;
- Pregnant or breastfeeding women, or who plan to become pregnant during the study;
- Subject is participating in other drug or medical device clinical trials at the time of signing informed consent;
- Other conditions judged by the investigators as unsuitable for enrollment.
Trial locations and contacts
14 sites in 1 country.
Jin Zheng contact
14 sites in 1 country
China14 sites, 13 recruiting
- Recruiting
Xuanwu hospital Capital Medical University
Beijing
Peng Zhang
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin
Xuan Chen
- Recruiting
Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
Chengdu
Tian Zhang
- Not yet recruiting
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong
Wenfeng Feng
- Not yet recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Chuanzhi Duan
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou
Guangzhong Chen
- Not yet recruiting
Anhui Provincial Hospital
Hefei
Ge Gao
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Donghai Wang
- Not yet recruiting
Jining No.1 People's Hospital
Jining
Feng Lei
- Not yet recruiting
General Hospital of Eastern Theater Command
Nanjing, Jiangsu
Xin Zhang
- Not yet recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning
Guobiao Liang
- Not yet recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan
Jiang Xiaobing
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Tianxiao Li
- Active, not recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations: a Prospective, Multi-center, Randomized, Parallel Positive Controlled, Non-inferiority Trial
The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd. (Suzhou)) for the treatment of cerebrovascular malformations.
Read the detailed description
This is a prospective, multi-center, randomized, parallel positive controlled, non-inferiority trial. This clinical trial is conducted at more than 2 centers in China, and patients who intend to be treated with liquid embolic system for cerebrovascular malformations are enrolled. Eligible patients are randomized into experimental group using Liquid Embolic System (Tonbridge) or control group using Onyx Liquid Embolic System (Medtronic) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Liquid Embolic System (Tonbridge).
- Conditions
- Intracranial Arteriovenous Malformations
- Being tested
- Liquid Embolic System (Tonbridge), Onyx Liquid Embolic System (Medtronic)
- Medical subject headings
- Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Embolic System (Tonbridge)Device
Endovascular treatment with Liquid Embolic System (Tonbridge).
Onyx Liquid Embolic System (Medtronic)Device
Endovascular treatment with Onyx Liquid Embolic System (Medtronic).
| Study group | Role | What they receive |
|---|---|---|
| Liquid Embolic System (Tonbridge) | Experimental | Not described Receives: Device: Liquid Embolic System (Tonbridge) |
| Onyx Liquid Embolic System (Medtronic) | Active comparator | Not described Receives: Device: Onyx Liquid Embolic System (Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted Embolization Satisfaction Rate
Targeted embolization satisfaction is defined as achieving ≥50% occlusion of the targeted embolized area after treatment with liquid embolic system, which is determined by immediate postoperative cerebrovascular DSA.
Measured: intra-procedure
Secondary outcomes (7)
mRS score
mRS scores are assessed at each evaluation time point.
Measured: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
GOS score
GOS scores are assessed at each evaluation time point.
Measured: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Operation satisfaction rate
The 5-point Likert scale is used to evaluate operation satisfaction from three aspects: visualization, diffusion, and microcatheter withdrawal. "Operation satisfaction rate" is defined as the proportion of investigational devices or comparators with Likert score≥12 points.
Measured: intra-procedure
Incidence of major adverse events (MAEs)
MAEs are defined as intracranial hemorrhage and ischemic complications. Intracranial hemorrhage included intraoperative hemorrhage (puncture of blood-supplying arteries by catheters or guidewires, rupture of nidus, and injury to blood vessels during withdrawal of catheters) and delayed symptomatic hemorrhage in the postoperative period; and ischemic complications included intraoperative ischemic complications (displacement of liquid embolic agents, thrombosis, and so on) and postoperative symptomatic ischemic stroke. "Incidence of major adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
Measured: 1 month±7 days, 3 months±30 days post-procedure
Incidence of adverse events (AEs)
"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
Measured: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Incidence of serious adverse events (SAEs)
"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.
Measured: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Incidence of device deficiency
Device deficiency is the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions.
Measured: 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start27 Jun 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Arteriovenous MalformationsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ton-Bridge Medical Tech. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peng Zhang, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479343
- Sponsor's protocol ID
- SZTQ202401
- Status last verified
- Sep 2024
- First submitted
- 24 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations: a Prospective, Multi-center, Randomized, Parallel Positive Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06479343
- Acronym / sponsor ID
- SZTQ202401
- Conditions
- Intracranial Arteriovenous Malformations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Ton-Bridge Medical Tech. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Jun 2024 (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 purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd. (Suzhou)) for the treatment of cerebrovascular malformations.
Detailed description
This is a prospective, multi-center, randomized, parallel positive controlled, non-inferiority trial. This clinical trial is conducted at more than 2 centers in China, and patients who intend to be treated with liquid embolic system for cerebrovascular malformations are enrolled. Eligible patients are randomized into experimental group using Liquid Embolic System (Tonbridge) or control group using Onyx Liquid Embolic System (Medtronic) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Liquid Embolic System (Tonbridge).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid Embolic System (Tonbridge) | Experimental | Device: Liquid Embolic System (Tonbridge) |
| Onyx Liquid Embolic System (Medtronic) | Active comparator | Device: Onyx Liquid Embolic System (Medtronic) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 80 years, any gender;
- Subject is suitable for endovascular treatment of cerebrovascular malformations;
- Subject is able to understand the purpose of the study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
Key exclusion criteria (12 listed)
- Intracranial hemorrhage within 1 month prior to treatment;
- The targeted embolization area needs to receive other treatments (surgical resection, SRS, other embolic materials) at the same time;
- Combination of other cerebrovascular malformations, such as cavernous vascular malformation;
- Severe stenosis or occlusion of cerebral feeding artery requiring surgical intervention;
- Intracranial tumor requiring surgical intervention;
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 |
|---|---|---|
| Liquid Embolic System (Tonbridge)Endovascular treatment with Liquid Embolic System (Tonbridge). | Device | Liquid Embolic System (Tonbridge) |
| Onyx Liquid Embolic System (Medtronic)Endovascular treatment with Onyx Liquid Embolic System (Medtronic). | Device | Onyx Liquid Embolic System (Medtronic) |
Primary outcome
Targeted Embolization Satisfaction Rate
Time frame: intra-procedure
Targeted embolization satisfaction is defined as achieving ≥50% occlusion of the targeted embolized area after treatment with liquid embolic system, which is determined by immediate postoperative cerebrovascular DSA.
7 secondary outcomes
mRS score
Time frame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
GOS score
Time frame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Operation satisfaction rate
Time frame: intra-procedure
Incidence of major adverse events (MAEs)
Time frame: 1 month±7 days, 3 months±30 days post-procedure
Incidence of adverse events (AEs)
Time frame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Incidence of serious adverse events (SAEs)
Time frame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Incidence of device deficiency
Time frame: 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Jin Zheng contact
Peng Zhang principal investigator
Xuanwu Hospital, Beijing
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Embolic System (Tonbridge) and Onyx Liquid Embolic System (Medtronic) in people with Intracranial Arteriovenous Malformations, run by Ton-Bridge Medical Tech. Co., Ltd at 14 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 12 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Contact Jing Pan (18916099975, jing.pan@ton-bridge.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted Embolization Satisfaction Rate (time frame: intra-procedure). 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 19 Sep 2024.