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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Self-expanding Intracranial Stent (Tonbridge); Device: LVIS and LVIS Jr. (MicroVention)

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).

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ben Han; Phone Number: 17798683846; Email: ben.han@ton-bridge.com
• Study Contact Backup: Name: Jianing Zhang; Phone Number: 13941826987; Email: jn.zhang@ton-bridge.com

Study Locations

• China
  • Chongqing, China
    • Not yet recruiting
    • The First Affiliated Hospital of Chongqing Medical University
    • Principal Investigator: Xiaodong Zhang
  • Shanghai, China
    • Not yet recruiting
    • Changhai Hospital of Shanghai
    • Principal Investigator: Jianmin Liu
  • Anhui
    • Wuhu, Anhui, China
      • Not yet recruiting
      • The First Affiliated Hospital of Wannan Medical College
      • Principal Investigator: Zhenbao Li
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong Provincial People's Hospital
      • Principal Investigator: Guangzhong Chen
    • Guangzhou, Guangdong, China
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
    • Zhuhai, Guangdong, China
      • Not yet recruiting
      • Zhuhai People's Hospital
      • Principal Investigator: Guangsen Cheng
  • Hubei
    • Wuhan, Hubei, China
      • Not yet recruiting
      • Tongji Hospital Tongji Medical College of HUST
      • Principal Investigator: Ting Lei
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • Xiangya Hospital of Central South University
      • Principal Investigator: Fenghua Chen
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • General Hospital of eastern theater command
  • Liaoning
    • Shenyang, Liaoning, China
      • Not yet recruiting
      • General Hospital of Northern Theater Command
      • Principal Investigator: Guobiao Liang
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Qilu Hospital of Shandong University
      • Principal Investigator: Donghai Wang
  • Shanxi
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • First Hospital Of ShanXi Medical University
      • Principal Investigator: Geng Guo
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
      • Principal Investigator: Tian Zhang
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • The First Affiliated Hospital Zhejiang University School of Medicine
      • Principal Investigator: Jianwei Pan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Self-expanding Intracranial Stent (Tonbridge)	Device: Self-expanding Intracranial Stent (Tonbridge); Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).
Active Comparator: control group; LVIS and LVIS Jr. (MicroVention)	Device: LVIS and LVIS Jr. (MicroVention); Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months±30 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	180±30 days, 360±30 days post-procedure
Incidence of stroke	Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.	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.	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.	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.	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.	intra-procedure, 180±30 days post-procedure

Collaborators and Investigators

• Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Investigators: Principal Investigator: Chuanzhi Duan, Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Estimate): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: ZHTQ202202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No