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The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

Primary Purpose

Intracranial Atherosclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intracranial Stent (Tonbridge)
Wingspan Stent System (Stryker Neurovascular)
Sponsored by
Zhuhai Tonbridge Medical Tech. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Atherosclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-75; Subjects with symptomatic intracranial atherosclerotic stenosis who do not respond to antiplatelet therapy or have poor compensation of collateral circulation and hypoperfusion in the offending vessel blood supply; The last onset time of TIA is not limited or the last onset of ischemic stroke is more than 2 weeks; The lesion is confirmed to be located in intracranial large arteries, including intracranial segment of the internal carotid artery, middle cerebral artery, intracranial segment of vertebral artery and the basilar artery; Target vessel diameter≥2.0mm and ≤4.5mm, lesion length ≤33mm; Stenosis degree of intracranial arteries≥70% and ≤99% measured by intracranial angiography (WASID method); Intracranial artery stenosis which requiring interventional treatment is a single lesion; Subjects have at least 1 atherosclerotic plaque risk factor including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, and smoking history; mRS≤2 before enrollment; Voluntarily participate in this study and sign the informed consent form, can complete examinations and follow-ups in accordance with the requirements of the protocol during the clinical trial. Exclusion Criteria: Intracranial arterial stenosis caused by non-atherosclerotic lesions: such as arterial dissection, moyamoya disease, vasculitis, active arteritis, etc.; Preoperative MRI shows only perforator infarction in the target lesion; Preoperative CT or MRI indicates the presence of post-infarct hemorrhagic transformation in the target vascular, or a history of subarachnoid, subdural, and epidural hemorrhage within 30 days before procedure, or the presence of untreated chronic subdural hematoma (≥5mm); Severe calcification of target vessels; or target vessel tortuosity or other reasons will make experimental device difficult to reach the target lesion position; There is more than 70% stenosis in the distal intracranial large vessels or proximal intracranial and extracranial large vessels of the target vessels, and the presence of unidentified responsible lesions; Subjects have a major surgery within 30 days before procedure or intend to be hospitalized for other procedure within 6 months after procedure; Intracranial tumors or intracranial arteriovenous malformations, or distal and proximal target vessels combined with aneurysms; The target lesion has a history of stent implantation; It is suspected that there is severe allergy or contraindication to aspirin, clopidogrel, heparin, contrast media, nitinol and other drugs and devices related to endovascular therapy; There is an underlying source of cardiac thrombus, such as atrial fibrillation, left ventricular thrombus, myocardial infarction within 30 days; Subjects with an INR > 1.5 or the presence of nonmodifiable bleeding factors; Medically uncontrolled severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg); Severe comorbid conditions or unstable conditions, such as severe heart failure, pulmonary failure, or renal failure (serum creatinine >3.0 mg/dL (264μmol/L)), severe liver insufficiency (ALT or AST >3 times normal), and malignancy; Life expectancy is less than two years; Women who are pregnant or breastfeeding; Subjects unable to complete follow-up due to cognitive impairment, mood disorder, or mental illness; Subjects who are enrolled in other clinical trials of drugs/devices and have not yet met the primary endpoint; Other circumstances which investigators do not consider are appropriate for intracranial stent treatment.

Sites / Locations

  • The First Affiliated Hospital of Henan Science & Technology University
  • Zhongnan Hospital of Wuhan University
  • Nanjing Drum Tower Hospital
  • Jiangxi Provincial People's Hospital
  • The First Hospital of Jilin University
  • The First Affiliated Hospital of Dalian Medical University
  • Baotou City Central Hospital
  • First Affiliated Hospital of Kunming Medical University
  • Hangzhou First People's Hospital
  • Ningbo First Hospital
  • Changhai Hospital of Shanghai
  • Shanghai Fourth People's Hospital
  • Tongji Hospitai of Tongji University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

Intracranial Stent (Tonbridge)

Wingspan Stent System (Stryker Neurovascular)

Outcomes

Primary Outcome Measures

Incidence of any stroke and death within 30 days
Stroke includes both ischemic and hemorrhagic stroke. Death includes death due to any cause.

Secondary Outcome Measures

Incidence of in-stent restenosis at 6 months, 12 months, and 24 months
ISR was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss. The degree of intracranial artery stenosis will be measured qualitatively in DSA or CTA examination with WASID method.
Incidence of symptomatic in-stent restenosis at 6 months, 12 months, and 24 months
Symptomatic in-stent restenosis is defined as ischemic stroke or TIA or other ischemic neurological symptoms which are caused by in-stent restenosis.
Device success rate
Device success refers to the successful delivery of the stent to the lesion site through the delivery system during procedure, and the stent is deployed well without bending and displacement.
Procedural success rate
Procedural success is defined as stenosis degree less than 30% immediately after procedure.
Ratio of mRS 0-2 at 30 days, 6 months, 12 months, and 24 months
Subjects will be evaluated at the follow-up visits with mRS. mRS 0-2 indicates a good prognosis.
Mortality at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Incidence of ischemic stroke in the target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Incidence of ischemic stroke in non-target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Incidence of any hemorrhagic stroke at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
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. Possible device deficiency: labeling errors, product quality problems, design defects, broken sterilization packaging, etc.
Incidence of adverse events (AE) at 30 days, 6 months, 12 months, and 24 months
Incidence of serious adverse events (SAE) at 30 days, 6 months, 12 months, and 24 months

Full Information

First Posted
February 22, 2023
Last Updated
March 3, 2023
Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05757505
Brief Title
The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Official Title
The Efficacy and Safety of the Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 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 verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of symptomatic intracranial atherosclerotic stenosis.
Detailed Description
This is a prospective, multicenter, randomized controlled, non-inferiority clinical trial carried out in 13 centers throughout China. 200 subjects with symptomatic intracranial atherosclerotic stenosis will be treated with the Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) or the Wingspan Stent System (Stryker Neurovascular) for the expansion of vascular stenosis site. The primary objective of this study is to evaluate the effectiveness and safety of the intracranial stent for endovascular treatment of symptomatic intracranial atherosclerotic stenosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Intracranial Stent (Tonbridge)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Wingspan Stent System (Stryker Neurovascular)
Intervention Type
Device
Intervention Name(s)
Intracranial Stent (Tonbridge)
Intervention Description
Endovascular treatment with Intracranial Stent (Tonbridge).
Intervention Type
Device
Intervention Name(s)
Wingspan Stent System (Stryker Neurovascular)
Intervention Description
Endovascular treatment with Wingspan Stent System (Stryker Neurovascular).
Primary Outcome Measure Information:
Title
Incidence of any stroke and death within 30 days
Description
Stroke includes both ischemic and hemorrhagic stroke. Death includes death due to any cause.
Time Frame
30±7 days post-procedure
Secondary Outcome Measure Information:
Title
Incidence of in-stent restenosis at 6 months, 12 months, and 24 months
Description
ISR was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss. The degree of intracranial artery stenosis will be measured qualitatively in DSA or CTA examination with WASID method.
Time Frame
6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure
Title
Incidence of symptomatic in-stent restenosis at 6 months, 12 months, and 24 months
Description
Symptomatic in-stent restenosis is defined as ischemic stroke or TIA or other ischemic neurological symptoms which are caused by in-stent restenosis.
Time Frame
6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure
Title
Device success rate
Description
Device success refers to the successful delivery of the stent to the lesion site through the delivery system during procedure, and the stent is deployed well without bending and displacement.
Time Frame
intra-procedure
Title
Procedural success rate
Description
Procedural success is defined as stenosis degree less than 30% immediately after procedure.
Time Frame
intra-procedure
Title
Ratio of mRS 0-2 at 30 days, 6 months, 12 months, and 24 months
Description
Subjects will be evaluated at the follow-up visits with mRS. mRS 0-2 indicates a good prognosis.
Time Frame
30±7 days, 6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure
Title
Mortality at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Time Frame
31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
Title
Incidence of ischemic stroke in the target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Time Frame
31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
Title
Incidence of ischemic stroke in non-target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Time Frame
31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
Title
Incidence of any hemorrhagic stroke at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Time Frame
31 days to 6 months, 6 to 12 months, and 12 to 24 months 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. Possible device deficiency: labeling errors, product quality problems, design defects, broken sterilization packaging, etc.
Time Frame
After use of device to end of study, assess up to 24 months
Title
Incidence of adverse events (AE) at 30 days, 6 months, 12 months, and 24 months
Time Frame
Through 24 months post-procedure
Title
Incidence of serious adverse events (SAE) at 30 days, 6 months, 12 months, and 24 months
Time Frame
Through 24 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75; Subjects with symptomatic intracranial atherosclerotic stenosis who do not respond to antiplatelet therapy or have poor compensation of collateral circulation and hypoperfusion in the offending vessel blood supply; The last onset time of TIA is not limited or the last onset of ischemic stroke is more than 2 weeks; The lesion is confirmed to be located in intracranial large arteries, including intracranial segment of the internal carotid artery, middle cerebral artery, intracranial segment of vertebral artery and the basilar artery; Target vessel diameter≥2.0mm and ≤4.5mm, lesion length ≤33mm; Stenosis degree of intracranial arteries≥70% and ≤99% measured by intracranial angiography (WASID method); Intracranial artery stenosis which requiring interventional treatment is a single lesion; Subjects have at least 1 atherosclerotic plaque risk factor including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, and smoking history; mRS≤2 before enrollment; Voluntarily participate in this study and sign the informed consent form, can complete examinations and follow-ups in accordance with the requirements of the protocol during the clinical trial. Exclusion Criteria: Intracranial arterial stenosis caused by non-atherosclerotic lesions: such as arterial dissection, moyamoya disease, vasculitis, active arteritis, etc.; Preoperative MRI shows only perforator infarction in the target lesion; Preoperative CT or MRI indicates the presence of post-infarct hemorrhagic transformation in the target vascular, or a history of subarachnoid, subdural, and epidural hemorrhage within 30 days before procedure, or the presence of untreated chronic subdural hematoma (≥5mm); Severe calcification of target vessels; or target vessel tortuosity or other reasons will make experimental device difficult to reach the target lesion position; There is more than 70% stenosis in the distal intracranial large vessels or proximal intracranial and extracranial large vessels of the target vessels, and the presence of unidentified responsible lesions; Subjects have a major surgery within 30 days before procedure or intend to be hospitalized for other procedure within 6 months after procedure; Intracranial tumors or intracranial arteriovenous malformations, or distal and proximal target vessels combined with aneurysms; The target lesion has a history of stent implantation; It is suspected that there is severe allergy or contraindication to aspirin, clopidogrel, heparin, contrast media, nitinol and other drugs and devices related to endovascular therapy; There is an underlying source of cardiac thrombus, such as atrial fibrillation, left ventricular thrombus, myocardial infarction within 30 days; Subjects with an INR > 1.5 or the presence of nonmodifiable bleeding factors; Medically uncontrolled severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg); Severe comorbid conditions or unstable conditions, such as severe heart failure, pulmonary failure, or renal failure (serum creatinine >3.0 mg/dL (264μmol/L)), severe liver insufficiency (ALT or AST >3 times normal), and malignancy; Life expectancy is less than two years; Women who are pregnant or breastfeeding; Subjects unable to complete follow-up due to cognitive impairment, mood disorder, or mental illness; Subjects who are enrolled in other clinical trials of drugs/devices and have not yet met the primary endpoint; Other circumstances which investigators do not consider are appropriate for intracranial stent treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long Chen
Phone
13868091267
Email
long.chen@ton-bridge.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuhan Yan
Phone
15843291055
Email
yh.yan@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
Shouchun Wang
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Henan Science & Technology University
City
Luoyang
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jisheng Qi
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumin Liu
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Xu
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenfeng Cao
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shouchun Wang
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Wang
Facility Name
Baotou City Central Hospital
City
Baotou
State/Province
Neimenggu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changchun Jiang
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Chen
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Congguo Yin
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengjun Zhou
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu
Facility Name
Shanghai Fourth People's Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yibin Fang
Facility Name
Tongji Hospitai of Tongji University
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Fang

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

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