Back to resultsA Single-arm Trial 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)
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;
- A single unruptured intracranial aneurysm locates in the intracranial segment of internal carotid artery (ICA) or vertebral artery (VA), which diagnosed by DSA;
- The maximal diameter of the target aneurysm < 10 mm diagnosed by DSA;
- The target aneurysm with a neck ≥ 4 mm or a dome to neck ratio < 2 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:
- Cerebrovascular malformations in the territory of the target aneurysm;
- Intracranial hemorrhage within 30 days pre-procedure;
- Modified Rankin Scale (mRS) score ≥ 3 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 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);
- Subject who 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, stent in the target lesion of parent artery, 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 Wannan Medical CollegeRecruiting
- Henan Provincial People's HospitalRecruiting
- Nanjing Drum Tower HospitalRecruiting
- Zhejiang HospitalRecruiting
- Xinqiao Hospital, Army Medical UniversityRecruiting
- Changhai Hospital of ShanghaiRecruiting
- Huashan Hospital Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flow Diverter (Tonbridge)
Arm Description
Treatment with Flow Diverter (Tonbridge)
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.
Successful occlusion rate of aneurysms at 12 months
Successful occlusion is defined as Raymond-Roy class I or II, which is diagnosed by DSA at 12 months post-procedure.
Incidence of new-onset stroke in the territory supplied by the treated artery or neurologic death at 12 months
New-onset stroke is defined as the occurrence of new stroke with an increase of ≥ 4 points in the subjects' NIHSS score from preoperative baseline. Neurologic death is defined as death due to neurologic reasons directly.
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 any stroke
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
Incidence of parent artery stenosis ( > 50%）in target area at 12 months
Parent artery stenosis in target area is defined as stenosis degree > 50%. Using postoperative cerebrovascular DSA at 12 months is performed to determine.
Incidence of parent artery occlusion in target area at 12 months
Postoperative cerebrovascular DSA at 12 months is performed to determine whether parent artery in target area is occluded.
Incidence of adverse events
"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device.
Incidence of serious adverse events
"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device.
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 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
NCT04918420
First Posted
May 31, 2021
Last Updated
September 22, 2023
Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04918420
Brief Title
A Single-arm Trial 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, Single-arm Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
June 2027 (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 effectiveness and safety of the Flow Diverter (Tonbridge) by collecting data from subjects who receive endovascular treatment of intracranial aneurysms.
Detailed Description
This is a prospective, multi-center, single-arm clinical trial carried out in 7 research centers over China. In this study, enrolled patients are treated with the Flow Diverter (Tonbridge) for intracranial aneurysms. The objective of this study is to evaluate the effectiveness and safety of the Flow Diverter (Tonbridge) for treatment of intracranial aneurysms.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flow Diverter (Tonbridge)
Arm Type
Experimental
Arm Description
Treatment with Flow Diverter (Tonbridge)
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.
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±30 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
Successful occlusion rate of aneurysms at 12 months
Description
Successful occlusion is defined as Raymond-Roy class I or II, which is diagnosed by DSA at 12 months post-procedure.
Time Frame
360±30 days post-procedure
Title
Incidence of new-onset stroke in the territory supplied by the treated artery or neurologic death at 12 months
Description
New-onset stroke is defined as the occurrence of new stroke with an increase of ≥ 4 points in the subjects' NIHSS score from preoperative baseline. Neurologic death is defined as death due to neurologic reasons directly.
Time Frame
360±30 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 any stroke
Description
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
Time Frame
30±7 days, 360±30 days post-procedure
Title
Incidence of parent artery stenosis ( > 50%）in target area at 12 months
Description
Parent artery stenosis in target area is defined as stenosis degree > 50%. Using postoperative cerebrovascular DSA at 12 months is performed to determine.
Time Frame
360±30 days post-procedure
Title
Incidence of parent artery occlusion in target area at 12 months
Description
Postoperative cerebrovascular DSA at 12 months is performed to determine whether parent artery in target area is occluded.
Time Frame
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.
Time Frame
pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 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.
Time Frame
pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 180±30 days, 360±30 days post-procedure
Title
Mortality rate
Description
Deaths due to any cause are calculated.
Time Frame
30±7 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 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
intra-procedure, 360±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;
A single unruptured intracranial aneurysm locates in the intracranial segment of internal carotid artery (ICA) or vertebral artery (VA), which diagnosed by DSA;
The maximal diameter of the target aneurysm < 10 mm diagnosed by DSA;
The target aneurysm with a neck ≥ 4 mm or a dome to neck ratio < 2 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 with cerebrovascular malformations;
Intracranial hemorrhage within 30 days pre-procedure;
Modified Rankin Scale (mRS) score ≥ 3 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 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);
Subject who 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, stent in the target lesion of parent artery, 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 Wannan Medical College
City
Wuhu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenbao Li
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianxiao Li
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingrong Zhang
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu Wan
Facility Name
Xinqiao Hospital, Army Medical University
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengqing Lv
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
A Single-arm Trial of the Flow Diverter (Tonbridge) For Endovascular Treatment of Intracranial Aneurysms
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