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Intracranial AneurysmNCT04918420

A Single-arm Trial of the Flow Diverter (Tonbridge) For Endovascular Treatment of Intracranial Aneurysms

A study testing Flow Diverter (Tonbridge) in people with Intracranial Aneurysm, run by Ton-Bridge Medical Tech. Co., Ltd at 7 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 effectiveness and safety of the Flow Diverter (Tonbridge) by collecting data from subjects who receive 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)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
7 sitesChina
Study dates
7 Jul 2021to 9 Mar 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;
  • A single unruptured intracranial aneurysm locates in the intracranial segment of internal carotid artery (ICA) or vertebral artery (VA), which diagnosed by DSA;
  • The maximal diameter of the target aneurysm < 10 mm diagnosed by DSA;
  • The target aneurysm with a neck ≥ 4 mm or a dome to neck ratio < 2 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 with cerebrovascular malformations;
  • Intracranial hemorrhage within 30 days pre-procedure;
  • Modified Rankin Scale (mRS) score ≥ 3 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 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);
  • Subject who 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, stent in the target lesion of parent artery, 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

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Xinqiao Hospital, Army Medical University

    Chongqing

  • Zhejiang Hospital

    Hangzhou, Zhejiang

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Changhai Hospital of Shanghai

    Shanghai

  • Huashan Hospital Fudan University

    Shanghai

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: A Prospective, Multi-center, Single-arm Trial

The purpose of this study is to assess the effectiveness and safety of the Flow Diverter (Tonbridge) by collecting data from subjects who receive endovascular treatment of intracranial aneurysms.

Read the detailed description

This is a prospective, multi-center, single-arm clinical trial carried out in 7 research centers over China. In this study, enrolled patients are treated with the Flow Diverter (Tonbridge) for intracranial aneurysms. The objective of this study is to evaluate the effectiveness and safety of the Flow Diverter (Tonbridge) for treatment of intracranial aneurysms.

Being tested
Flow Diverter (Tonbridge)
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.

Study groups in NCT04918420
Study groupRoleWhat they receive
Flow Diverter (Tonbridge)ExperimentalTreatment with Flow Diverter (Tonbridge)
Receives: Device: Flow Diverter (Tonbridge)

What is being measured

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

  1. 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±30 days post-procedure

Secondary outcomes (13)

  1. 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

  2. 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

  3. Successful occlusion rate of aneurysms at 12 months

    Successful occlusion is defined as Raymond-Roy class I or II, which is diagnosed by DSA at 12 months post-procedure.

    Measured: 360±30 days post-procedure

  4. Incidence of new-onset stroke in the territory supplied by the treated artery or neurologic death at 12 months

    New-onset stroke is defined as the occurrence of new stroke with an increase of ≥ 4 points in the subjects' NIHSS score from preoperative baseline. Neurologic death is defined as death due to neurologic reasons directly.

    Measured: 360±30 days post-procedure

  5. 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

  6. Incidence of any stroke

    Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.

    Measured: 30±7 days, 360±30 days post-procedure

  7. Incidence of parent artery stenosis ( > 50%）in target area at 12 months

    Parent artery stenosis in target area is defined as stenosis degree > 50%. Using postoperative cerebrovascular DSA at 12 months is performed to determine.

    Measured: 360±30 days post-procedure

  8. Incidence of parent artery occlusion in target area at 12 months

    Postoperative cerebrovascular DSA at 12 months is performed to determine whether parent artery in target area is occluded.

    Measured: 360±30 days post-procedure

  9. Incidence of adverse events

    "Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device.

    Measured: pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 180±30 days, 360±30 days post-procedure

  10. Incidence of serious adverse events

    "Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device.

    Measured: pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 180±30 days, 360±30 days post-procedure

  11. Mortality rate

    Deaths due to any cause are calculated.

    Measured: 30±7 days, 360±30 days post-procedure

  12. 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 with Likert score ≥ 12 points.

    Measured: intra-procedure

  13. 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: intra-procedure, 360±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.

  1. First posted8 Jun 2021
  2. Study start7 Jul 2021
  3. Primary completion9 Mar 2023
  4. Study completion9 Mar 2023

Resources

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
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04918420
Sponsor's protocol ID
ZHTQ2021002
Status last verified
Dec 2025
First submitted
31 May 2021
Last updated
2 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Flow Diverter (Tonbridge) in people with Intracranial Aneurysm, run by Ton-Bridge Medical Tech. Co., Ltd at 7 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 6 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 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 7 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±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 NCT04918420.

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.

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