Skip to main content
OpenTrials
Completed

NCT Number: NCT05755516

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

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. (MicroVention Europe SARL) for endovascular treatment of intracranial aneurysms.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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；
  • 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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Device success rate

    Time frame: intra-procedure

    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.

  2. Immediate successful occlusion rate of aneurysms

    Time frame: intra-procedure

    Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by intraoperative cerebrovascular DSA.

  3. Recurrence rate of aneurysms at 6 months

    Time frame: 6 months±30 days post-procedure

    Recurrence is defined as increased contrast agent filling into the aneurysm sac at post-operative review compared to immediate post-procedure.

  4. Retreatment rate

    Time frame: 180±30 days, 360±30 days post-procedure

    Retreatment is defined as during the study period any additional treatment of the target aneurysm after the original procedure.

  5. Operation satisfaction rate

    Time frame: intra-procedure

    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.

  6. Incidence of parent artery stenosis (>50%) in target area

    Time frame: 180±30 days, 360±30 days post-procedure

    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.

  7. Incidence of parent artery occlusion in target area

    Time frame: 180±30 days, 360±30 days post-procedure

    Parent artery occlusion in target area is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months.

  8. Incidence of stroke

    Time frame: 30±7 days, 360±30 days post-procedure

    Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.

  9. All-cause mortality

    Time frame: 30±7 days, 360±30 days post-procedure

    "All-cause mortality" is the proportion of subjects who die due to any cause.

  10. Incidence of adverse events

    Time frame: 180±30 days, 360±30 days post-procedure

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

  11. Incidence of serious adverse events

    Time frame: 180±30 days, 360±30 days post-procedure

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

  12. Incidence of device deficiency

    Time frame: intra-procedure, 180±30 days post-procedure

    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.

Sponsors and collaborators

Lead sponsor

Ton-Bridge Medical Tech. Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2023
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.