Back to resultsEfficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
Primary Purpose
Intracranial Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Self-expanding Intracranial Stent (Tonbridge)
LVIS and LVIS Jr. (MicroVention)
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; 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.
Sites / Locations
- The First Affiliated Hospital of Wannan Medical College
- Guangdong Provincial People's Hospital
- Zhujiang Hospital of Southern Medical UniversityRecruiting
- Zhuhai People's Hospital
- Tongji Hospital Tongji Medical College of HUST
- Xiangya Hospital of Central South University
- General Hospital of Eastern Theater Command
- General Hospital of Northern Theater Command
- Qilu Hospital of Shandong University
- First Hospital of Shanxi Medical University
- Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
- The First Affiliated Hospital Zhejiang University School of Medicine
- The First Affiliated Hospital of Chongqing Medical University
- Changhai Hospital of Shanghai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
control group
Arm Description
Self-expanding Intracranial Stent (Tonbridge)
LVIS and LVIS Jr. (MicroVention)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Retreatment rate
Retreatment is defined as during the study period any additional treatment of the target aneurysm after the original 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.
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.
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.
Incidence of stroke
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
All-cause mortality
"All-cause mortality" is the proportion of subjects who die due to any cause.
Incidence of 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
"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.
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.
Full Information
NCT ID
NCT05755516
First Posted
February 21, 2023
Last Updated
March 3, 2023
Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05755516
Brief Title
Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
April 2025 (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
5. Study Description
Brief Summary
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.
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).
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
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Self-expanding Intracranial Stent (Tonbridge)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
LVIS and LVIS Jr. (MicroVention)
Intervention Type
Device
Intervention Name(s)
Self-expanding Intracranial Stent (Tonbridge)
Intervention Description
Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).
Intervention Type
Device
Intervention Name(s)
LVIS and LVIS Jr. (MicroVention)
Intervention Description
Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).
Primary Outcome Measure Information:
Title
Successful occlusion rate of aneurysms at 6 months
Description
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.
Time Frame
6 months±30 days post-procedure
Secondary Outcome Measure Information:
Title
Device success rate
Description
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.
Time Frame
intra-procedure
Title
Immediate successful occlusion rate of aneurysms
Description
Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by intraoperative cerebrovascular DSA.
Time Frame
intra-procedure
Title
Recurrence rate of aneurysms at 6 months
Description
Recurrence is defined as increased contrast agent filling into the aneurysm sac at post-operative review compared to immediate post-procedure.
Time Frame
6 months±30 days post-procedure
Title
Retreatment rate
Description
Retreatment is defined as during the study period any additional treatment of the target aneurysm after the original procedure.
Time Frame
180±30 days, 360±30 days post-procedure
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 parent artery stenosis (>50%) in target area
Description
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.
Time Frame
180±30 days, 360±30 days post-procedure
Title
Incidence of parent artery occlusion in target area
Description
Parent artery occlusion in target area is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months.
Time Frame
180±30 days, 360±30 days post-procedure
Title
Incidence of stroke
Description
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
Time Frame
30±7 days, 360±30 days post-procedure
Title
All-cause mortality
Description
"All-cause mortality" is the proportion of subjects who die due to any cause.
Time Frame
30±7 days, 360±30 days post-procedure
Title
Incidence of adverse events
Description
"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
Time Frame
180±30 days, 360±30 days post-procedure
Title
Incidence of serious adverse events
Description
"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.
Time Frame
180±30 days, 360±30 days post-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 and malfunctions.
Time Frame
intra-procedure, 180±30 days post-procedure
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ben Han
Phone
17798683846
Email
ben.han@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
First Name & Middle Initial & Last Name & Degree
Chuanzhi Duan
Organizational Affiliation
Southern Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenbao Li
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangzhong Chen
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanzhi Duan
Facility Name
Zhuhai People's Hospital
City
Zhuhai
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangsen Cheng
Facility Name
Tongji Hospital Tongji Medical College of HUST
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Lei
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fenghua Chen
Facility Name
General Hospital of Eastern Theater Command
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zhang
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guobiao Liang
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donghai Wang
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geng Guo
Facility Name
Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tian Zhang
Facility Name
The First Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianwei Pan
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Zhang
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
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