Back to resultsEfficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
Primary Purpose
Intracranial Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Flow Diverter (Tonbridge)
Tubridge (MicroPort)
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm
Eligibility Criteria
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 cerebrovascular malformations in the territory of the target aneurysm;
- 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.
Sites / Locations
- The First Affiliated Hospital of USTC
- Nanfang Hospital Southern Medical University
- Zhujiang Hospital of Southern Medical University
- Nanyang Central Hospital
- The First Affiliated Hospital of Zhengzhou University
- Yichang Central People's Hospital
- Hunan Provincial People's Hospital
- Jiangsu Province Hospital
- The Second Affiliated Hospital of Nanchang University
- The Second Affiliated Hospital Zhejiang University School of Medicine
- Zhejiang Hospital
- Changhai Hospital of ShanghaiRecruiting
- Huashan Hospital Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Flow Diverter (Tonbridge)
Tubridge (MicroPort)
Arm Description
Treatment with Flow Diverter (Tonbridge)
Treatment with Tubridge (MicroPort)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Immediate procedural success rate
Intraoperative cerebrovascular DSA is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.
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.
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.
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.
Incidence of stroke
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
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.
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.
Mortality rate
Deaths due to any cause are calculated.
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.
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.
Full Information
NCT ID
NCT04799964
First Posted
February 20, 2021
Last Updated
September 22, 2023
Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04799964
Brief Title
Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flow Diverter (Tonbridge)
Arm Type
Experimental
Arm Description
Treatment with Flow Diverter (Tonbridge)
Arm Title
Tubridge (MicroPort)
Arm Type
Active Comparator
Arm Description
Treatment with Tubridge (MicroPort)
Intervention Type
Device
Intervention Name(s)
Flow Diverter (Tonbridge)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Tubridge (MicroPort)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete occlusion rate of aneurysms at 12 months
Description
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.
Time Frame
360±45 days post-procedure
Secondary Outcome Measure Information:
Title
Immediate procedural success rate
Description
Intraoperative cerebrovascular DSA is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.
Time Frame
intra-procedure
Title
Complete occlusion rate of aneurysms at 6 months
Description
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.
Time Frame
180±30 days post-procedure
Title
Subtotal occlusion rate
Description
Subtotal occlusion is defined as contrast agents in the aneurysm sac less than 10% which is diagnosed by DSA at 12 months post-procedure.
Time Frame
360±45 days post-procedure
Title
Incidence of technical complications
Description
Technical complications include but not limited to: stent incomplete opening, stent migration, stent herniation into the aneurysm sac, in-stent thrombosis, operation injury, etc.
Time Frame
intra-procedure
Title
Incidence of stroke
Description
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
Time Frame
within 360±45 days
Title
Incidence of parent artery stenosis ( > 50%) in target area at 360 days and incidence of parent artery occlusion in target area at 360 days
Description
Parent artery stenosis in target area is defined as stenosis degree > 50%. Using postoperative cerebrovascular DSA at 360 days is performed to determine.
Time Frame
360±45 days post-procedure
Title
Incidence of adverse events and incidence of serious adverse events
Description
"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.
Time Frame
within 360±45 days
Title
Mortality rate
Description
Deaths due to any cause are calculated.
Time Frame
within 360±45 days
Title
Operation satisfaction rate
Description
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.
Time Frame
intra-procedure
Title
Incidence of device deficiency
Description
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.
Time Frame
within 360±45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danqing Shen
Phone
15858207851
Email
dq.shen@ton-bridge.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianing Zhang
Phone
13941826987
Email
jn.zhang@ton-bridge.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of USTC
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanfang Hospital Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanyang Central Hospital
City
Nanyang
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Yichang Central People's Hospital
City
Yichang
State/Province
Hubei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu
Facility Name
Huashan Hospital Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxiang Gu
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
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