Intracranial AneurysmNCT04799964
Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
A study testing Flow Diverter (Tonbridge) and Tubridge (MicroPort) in people with Intracranial Aneurysm, run by Ton-Bridge Medical Tech. Co., Ltd at 13 sites in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Flow Diverter (Tonbridge) and Tubridge (MicroPort)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 13 sitesChina
- Study dates
- 12 Aug 2021to 22 Sep 2023
- 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;
- Unruptured intracranial aneurysms locate in the internal carotid artery (ICA) or vertebral artery (VA) with a neck ≥ 4 mm and a maximal diameter ≥ 10 mm, which diagnosed by DSA;
- The target aneurysm with a parent vessel diameter of 2.0-6.5 mm;
- Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
Who cannot join
- Diagnosed as multiple aneurysms which cannot be covered by a single stent or with cerebrovascular malformations;
- Subarachnoid hemorrhage of the target aneurysm within 30 days pre-procedure;
- Modified Rankin Scale (mRS) score > 2 in pre-procedure;
- Platelet (PLT) < 60×10^9/L or known platelet dysfunction or International Normalized Ratio (INR) > 1.5;
- Heart, lung, liver and renal failure or other severe diseases (such as brain tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis);
- The lesion which is not appropriate for flow diverter delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, etc.);
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- Major surgery within 30 days before enrollment, or intending to receive surgery within 180 days after enrollment;
- Allergic history of anesthetics and contrast agents, or contraindication for dual antiplatelet or/and anticoagulant therapy;
- Allergic History of metals such as nickel-titanium alloy;
- Life expectancy < 12 months;
- Pregnant or breastfeeding women;
- Subject has participated in other drug or medical device clinical trials within 1 month before signing informed consent;
- Other conditions judged by the investigators as unsuitable for enrollment.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Hunan Provincial People's Hospital
Changsha, Hunan
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhejiang Hospital
Hangzhou, Zhejiang
The First Affiliated Hospital of USTC
Hefei, Anhui
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Jiangsu Province Hospital
Nanjing, Jiangsu
Nanyang Central Hospital
Nanyang, Henan
Changhai Hospital of Shanghai
Shanghai
Huashan Hospital Fudan University
Shanghai
Yichang Central People's Hospital
Yichang, Hubei
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: a Prospective, Multi-center, Randomized, Open, Positive-controlled, Non-inferiority Trial
The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.
Read the detailed description
This is a prospective, multi-center, randomized, open, positive-controlled, non-inferiority trial. This clinical trial is conducted at more than 5 centers in China. Eligible patients are randomized into experimental group using Flow Diverter (Tonbridge) or control group using Tubridge (MicroPort) in a 1:1 ratio. The primary objective of this study is to verify the complete occlusion rate of aneurysms at 12 months of Flow Diverter (Tonbridge) is non-inferior to Tubridge, for treatment of intracranial aneurysms, and evaluate the effectiveness and safety of the Flow Diverter (Tonbridge).
- Conditions
- Intracranial Aneurysm
- Being tested
- Flow Diverter (Tonbridge), Tubridge (MicroPort)
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow Diverter (Tonbridge)Device
The device is a self-expanding vascular stent system, which consists of a stent and a delivery system. The stent is made of platinum core nickel-titanium alloy material. The delivery system is composed of a delivery guide wire and an introducer sheath. The stent and the delivery guide wire are pre-installed in the introducer sheath.
Tubridge (MicroPort)Device
Tubridge consists of a stent system and a microcatheter system. The stent system consists of a stent and a conveyor, the stent is self-expanding as well.
| Study group | Role | What they receive |
|---|---|---|
| Flow Diverter (Tonbridge) | Experimental | Treatment with Flow Diverter (Tonbridge) Receives: Device: Flow Diverter (Tonbridge) |
| Tubridge (MicroPort) | Active comparator | Treatment with Tubridge (MicroPort) Receives: Device: Tubridge (MicroPort) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete occlusion rate of aneurysms at 12 months
Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by cerebrovascular DSA at 12 months post-procedure.
Measured: 360±45 days post-procedure
Secondary outcomes (10)
Immediate procedural success rate
Intraoperative cerebrovascular DSA is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.
Measured: intra-procedure
Complete occlusion rate of aneurysms at 6 months
Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by MRA/CTA at 6 months post-procedure.
Measured: 180±30 days post-procedure
Subtotal occlusion rate
Subtotal occlusion is defined as contrast agents in the aneurysm sac less than 10% which is diagnosed by DSA at 12 months post-procedure.
Measured: 360±45 days post-procedure
Incidence of technical complications
Technical complications include but not limited to: stent incomplete opening, stent migration, stent herniation into the aneurysm sac, in-stent thrombosis, operation injury, etc.
Measured: intra-procedure
Incidence of stroke
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
Measured: within 360±45 days
Incidence of parent artery stenosis ( > 50%) in target area at 360 days and incidence of parent artery occlusion in target area at 360 days
Parent artery stenosis in target area is defined as stenosis degree > 50%. Using postoperative cerebrovascular DSA at 360 days is performed to determine.
Measured: 360±45 days post-procedure
Incidence of adverse events and incidence of serious adverse events
"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator;
"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.
Measured: within 360±45 days
Mortality rate
Deaths due to any cause are calculated.
Measured: within 360±45 days
Operation satisfaction rate
The 5-point Likert scale is used to evaluate the operation satisfaction from three aspects: push performance, retracting performance and release performance. "Operation satisfaction rate" is defined as the proportion of investigational devices or comparators with Likert score ≥ 12 points.
Measured: intra-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, malfunctions, etc.
Measured: within 360±45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start12 Aug 2021
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ton-Bridge Medical Tech. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin Liu, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799964
- Sponsor's protocol ID
- ZHTQ2020001
- Status last verified
- Sep 2024
- First submitted
- 20 Feb 2021
- 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 Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: a Prospective, Multi-center, Randomized, Open, Positive-controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04799964
- Acronym / sponsor ID
- ZHTQ2020001
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Ton-Bridge Medical Tech. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 16 Mar 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.
The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.
Detailed description
This is a prospective, multi-center, randomized, open, positive-controlled, non-inferiority trial. This clinical trial is conducted at more than 5 centers in China. Eligible patients are randomized into experimental group using Flow Diverter (Tonbridge) or control group using Tubridge (MicroPort) in a 1:1 ratio. The primary objective of this study is to verify the complete occlusion rate of aneurysms at 12 months of Flow Diverter (Tonbridge) is non-inferior to Tubridge, for treatment of intracranial aneurysms, and evaluate the effectiveness and safety of the Flow Diverter (Tonbridge).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flow Diverter (Tonbridge) | Experimental | Device: Flow Diverter (Tonbridge)Treatment with Flow Diverter (Tonbridge) |
| Tubridge (MicroPort) | Active comparator | Device: Tubridge (MicroPort)Treatment with Tubridge (MicroPort) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80 years, any gender;
- Unruptured intracranial aneurysms locate in the internal carotid artery (ICA) or vertebral artery (VA) with a neck ≥ 4 mm and a maximal diameter ≥ 10 mm, which diagnosed by DSA;
- The target aneurysm with a parent vessel diameter of 2.0-6.5 mm;
- Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
Key exclusion criteria (13 listed)
- Diagnosed as multiple aneurysms which cannot be covered by a single stent or with cerebrovascular malformations;
- Subarachnoid hemorrhage of the target aneurysm within 30 days pre-procedure;
- Modified Rankin Scale (mRS) score > 2 in pre-procedure;
- Platelet (PLT) < 60×10^9/L or known platelet dysfunction or International Normalized Ratio (INR) > 1.5;
- Heart, lung, liver and renal failure or other severe diseases (such as brain tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis);
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 |
|---|---|---|
| Flow Diverter (Tonbridge)The device is a self-expanding vascular stent system, which consists of a stent and a delivery system. The stent is made of platinum core nickel-titanium alloy material. The delivery system is composed of a delivery guide wire and an introducer sheath. The stent and the delivery guide wire are pre-installed in the introducer sheath. | Device | Flow Diverter (Tonbridge) |
| Tubridge (MicroPort)Tubridge consists of a stent system and a microcatheter system. The stent system consists of a stent and a conveyor, the stent is self-expanding as well. | Device | Tubridge (MicroPort) |
Primary outcome
Complete occlusion rate of aneurysms at 12 months
Time frame: 360±45 days post-procedure
Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by cerebrovascular DSA at 12 months post-procedure.
10 secondary outcomes
Immediate procedural success rate
Time frame: intra-procedure
Complete occlusion rate of aneurysms at 6 months
Time frame: 180±30 days post-procedure
Subtotal occlusion rate
Time frame: 360±45 days post-procedure
Incidence of technical complications
Time frame: intra-procedure
Incidence of stroke
Time frame: within 360±45 days
Incidence of parent artery stenosis ( > 50%) in target area at 360 days and incidence of parent artery occlusion in target area at 360 days
Time frame: 360±45 days post-procedure
Incidence of adverse events and incidence of serious adverse events
Time frame: within 360±45 days
Mortality rate
Time frame: within 360±45 days
Operation satisfaction rate
Time frame: intra-procedure
Incidence of device deficiency
Time frame: within 360±45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Jianmin Liu principal investigator
Changhai Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow Diverter (Tonbridge) and Tubridge (MicroPort) in people with Intracranial Aneurysm, run by Ton-Bridge Medical Tech. Co., Ltd at 13 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 4 inclusion and 13 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 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 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete occlusion rate of aneurysms at 12 months (time frame: 360±45 days post-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.