Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Flow Diverter (Tonbridge); Device: Tubridge (MicroPort)

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 Type: Interventional
• Enrollment (Estimated): 187
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danqing Shen; Phone Number: 15858207851; Email: dq.shen@ton-bridge.com
• Study Contact Backup: Name: Jianing Zhang; Phone Number: 13941826987; Email: jn.zhang@ton-bridge.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Changhai Hospital of Shanghai
    • Principal Investigator: Jianmin Liu
  • Shanghai, China
    • Recruiting
    • Huashan Hospital Fudan University
    • Principal Investigator: Yuxiang Gu
  • Anhui
    • Hefei, Anhui, China
      • Active, not recruiting
      • The First Affiliated Hospital of Ustc
  • Guangdong
    • Guangzhou, Guangdong, China
      • Active, not recruiting
      • Nanfang Hospital Southern Medical University
    • Guangzhou, Guangdong, China
      • Active, not recruiting
      • Zhujiang Hospital of Southern Medical University
  • Henan
    • Nanyang, Henan, China
      • Active, not recruiting
      • Nanyang Central Hospital
    • Zhengzhou, Henan, China
      • Active, not recruiting
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Yichang, Hubei, China
      • Active, not recruiting
      • Yichang Central People's Hospital
  • Hunan
    • Changsha, Hunan, China
      • Active, not recruiting
      • Hunan Provincial People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Active, not recruiting
      • Jiangsu Province Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Active, not recruiting
      • The Second Affiliated Hospital of Nanchang University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Active, not recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Active, not recruiting
      • Zhejiang Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.);
• 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.

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: Flow Diverter (Tonbridge); Treatment with Flow Diverter (Tonbridge)	Device: 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.
Active Comparator: Tubridge (MicroPort); Treatment with Tubridge (MicroPort)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	360±45 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate procedural success rate	Intraoperative cerebrovascular DSA is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.	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.	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.	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.	intra-procedure
Incidence of stroke	Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.	within 360±45 days
Mortality rate	Deaths due to any cause are calculated.	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.	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.	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.	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.	within 360±45 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	intra-procedure
Incidence of stroke	Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.	within 360±45 days
Incidence of parent artery stenosis ( > 50%) and 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.	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 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.	within 360±45 days
Mortality rate	Deaths due to any cause are calculated.	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.	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.	within 360±45 days

Collaborators and Investigators

• Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Investigators: Principal Investigator: Jianmin Liu, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 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: ZHTQ2020001

Drug and device information, study documents

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