Intracranial AneurysmNCT05755516

Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

A study testing Self-expanding Intracranial Stent (Tonbridge) and LVIS and LVIS Jr. (MicroVention) in people with Intracranial Aneurysm, run by Ton-Bridge Medical Tech. Co., Ltd at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the efficacy and safety of Self-expanding Intracranial Stent (Tonbridge), by comparing the data obtained from Self-expanding Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) and LVIS/LVIS Jr. 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?: Self-expanding Intracranial Stent (Tonbridge) and LVIS and LVIS Jr. (MicroVention)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 204 participants
Where: 14 sitesChina
Study dates: 14 Feb 2023to 13 Dec 2024
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;
Diagnosed as intracranial aneurysm and the subject is assessed as suitable for stent-assisted coiling;
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

Aneurysm rupture within 30 days before enrollment;
Diagnosed as blood blister-like aneurysm, pseudoaneurysm, infected aneurysm, or aneurysm related to arteriovenous malformations;
Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
Modified Rankin Scale (mRS) score ≥3;
Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.);
Major surgery within 30 days before enrollment；

Show all 12Show fewer

Known coagulation dysfunction or contraindication to anticoagulant and antiplatelet therapy;
Known allergy to nickel-titanium alloy metal materials;
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

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

China14 sites

Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
Chengdu, Sichuan
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Qilu Hospital of Shandong University
Jinan, Shandong
General Hospital of Eastern Theater Command
Nanjing, Jiangsu
Changhai Hospital of Shanghai
Shanghai
General Hospital of Northern Theater Command
Shenyang, Liaoning
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
Zhuhai People's Hospital
Zhuhai, Guangdong

Other trials in China

About this study

Official title: Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: A Prospective, Multi-center, Randomized, Open, Parallel Positive Controlled, Non-inferiority Trial

Read the detailed description

This is a prospective, multi-center, randomized, open, 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 stent-assisted coiling for intracranial aneurysms are enrolled. Eligible patients are randomized into experimental group using Self-expanding Intracranial Stent (Tonbridge) or control group using LVIS and LVIS Jr. (MicroVention) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Self-expanding Intracranial Stent (Tonbridge).

Conditions: Intracranial Aneurysm
Being tested: Self-expanding Intracranial Stent (Tonbridge), LVIS and LVIS Jr. (MicroVention)
Medical subject headings: Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Self-expanding Intracranial Stent (Tonbridge)Device
Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).
LVIS and LVIS Jr. (MicroVention)Device
Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).

Study groups in NCT05755516
Study group	Role	What they receive
experimental group	Experimental	Self-expanding Intracranial Stent (Tonbridge) Receives: Device: Self-expanding Intracranial Stent (Tonbridge)
control group	Active comparator	LVIS and LVIS Jr. (MicroVention) Receives: Device: LVIS and LVIS Jr. (MicroVention)

What is being measured

The primary outcome is the main question the study is designed to answer.

Successful occlusion rate of aneurysms at 6 months
Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by cerebrovascular DSA at 6 months post-procedure.
Measured: 6 months±30 days post-procedure

Secondary outcomes (12)

Device success rate
Device success is that the stent is delivered to the target vessel successfully and covers the aneurysm neck effectively without stent migration or misplacement, etc. Device success is diagnosed by intraoperative cerebrovascular DSA.
Measured: intra-procedure
Immediate successful occlusion rate of aneurysms
Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by intraoperative cerebrovascular DSA.
Measured: intra-procedure
Recurrence rate of aneurysms at 6 months
Recurrence is defined as increased contrast agent filling into the aneurysm sac at post-operative review compared to immediate post-procedure.
Measured: 6 months±30 days post-procedure
Retreatment rate
Retreatment is defined as during the study period any additional treatment of the target aneurysm after the original procedure.
Measured: 180±30 days, 360±30 days post-procedure
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 parent artery stenosis (>50%) in target area
Parent artery stenosis in target area is defined as stenosis degree >50%, which is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months.
Measured: 180±30 days, 360±30 days post-procedure
Incidence of parent artery occlusion in target area
Parent artery occlusion in target area is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months.
Measured: 180±30 days, 360±30 days post-procedure
Incidence of stroke
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
Measured: 30±7 days, 360±30 days post-procedure
All-cause mortality
"All-cause mortality" is the proportion of subjects who die due to any cause.
Measured: 30±7 days, 360±30 days post-procedure
Incidence of adverse events
"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
Measured: 180±30 days, 360±30 days post-procedure
Incidence of serious adverse events
"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.
Measured: 180±30 days, 360±30 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: intra-procedure, 180±30 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 202313 Dec 2024

First posted6 Mar 2023
Study start14 Feb 2023
Primary completion10 Mar 2024
Study completion13 Dec 2024

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: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05755516
Sponsor's protocol ID: ZHTQ202202
Status last verified: Dec 2025
First submitted: 21 Feb 2023
Last updated: 2 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
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Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
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A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
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Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
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All Intracranial Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: A Prospective, Multi-center, Randomized, Open, Parallel Positive Controlled, Non-inferiority Trial
ClinicalTrials.gov ID: NCT05755516
Acronym / sponsor ID: ZHTQ202202
Conditions: Intracranial Aneurysm
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Ton-Bridge Medical Tech. Co., LtdIndustry (pharma, biotech, devices)
Study start: 14 Feb 2023 (actual)
Primary completion: 10 Mar 2024 (actual)
Study completion: 13 Dec 2024 (actual)
First posted: 6 Mar 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Device: Self-expanding Intracranial Stent (Tonbridge)Self-expanding Intracranial Stent (Tonbridge)
control group	Active comparator	Device: LVIS and LVIS Jr. (MicroVention)LVIS and LVIS Jr. (MicroVention)

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;
Diagnosed as intracranial aneurysm and the subject is assessed as suitable for stent-assisted coiling;
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 (12 listed)

Aneurysm rupture within 30 days before enrollment;
Diagnosed as blood blister-like aneurysm, pseudoaneurysm, infected aneurysm, or aneurysm related to arteriovenous malformations;
Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
Modified Rankin Scale (mRS) score ≥3;
Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.);

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
Self-expanding Intracranial Stent (Tonbridge)Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).	Device	experimental group
LVIS and LVIS Jr. (MicroVention)Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).	Device	control group

Primary outcome

Successful occlusion rate of aneurysms at 6 months
Time frame: 6 months±30 days post-procedure
Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by cerebrovascular DSA at 6 months post-procedure.

12 secondary outcomes

Device success rate
Time frame: intra-procedure
Immediate successful occlusion rate of aneurysms
Time frame: intra-procedure
Recurrence rate of aneurysms at 6 months
Time frame: 6 months±30 days post-procedure
Retreatment rate
Time frame: 180±30 days, 360±30 days post-procedure
Operation satisfaction rate
Time frame: intra-procedure
Incidence of parent artery stenosis (>50%) in target area
Time frame: 180±30 days, 360±30 days post-procedure
Incidence of parent artery occlusion in target area
Time frame: 180±30 days, 360±30 days post-procedure
Incidence of stroke
Time frame: 30±7 days, 360±30 days post-procedure
All-cause mortality
Time frame: 30±7 days, 360±30 days post-procedure
Incidence of adverse events
Time frame: 180±30 days, 360±30 days post-procedure
Incidence of serious adverse events
Time frame: 180±30 days, 360±30 days post-procedure
Incidence of device deficiency
Time frame: intra-procedure, 180±30 days post-procedure

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 2 Jan 2026.

Related trials for Intracranial Aneurysm

Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain

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

Chuanzhi Duan principal investigator

Southern Medical University, China

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Self-expanding Intracranial Stent (Tonbridge) and LVIS and LVIS Jr. (MicroVention) in people with Intracranial Aneurysm, 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: finished, as of the sponsor's last update on 2 Jan 2026. 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?

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?

Successful occlusion rate of aneurysms at 6 months (time frame: 6 months±30 days post-procedure). 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 NCT05755516.

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 2 Jan 2026.