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

The Efficacy and Safety of the Intracranial Stent (Tonbridge) in Endovascular Treatment of Intracranial Atherosclerotic Stenosis: A Prospective, Multicenter, Single-Arm Trial

The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of intracranial atherosclerotic stenosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Atherosclerosis
• Intervention / Treatment: Device: Intracranial Stent (Tonbridge)

Detailed Description

This is a prospective, multicenter, single-arm clinical trial carried out in 14 centers throughout China. 156 subjects with intracranial atherosclerotic stenosis will be treated with the Intracranial Stent (Tonbridge) 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 intracranial atherosclerotic stenosis.

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Long Chen; Phone Number: 13868091267; Email: long.chen@ton-bridge.com
• Study Contact Backup: Name: Yuhan Yan; Phone Number: 15843291055; Email: yh.yan@ton-bridge.com

Study Locations

• China
  • Shanghai, China
    • Changhai Hospital of Shanghai
    • Principal Investigator: Jianmin Liu
  • Shanghai, China
    • Tongji Hospitai of Tongji University
    • Principal Investigator: Chun Fang
  • Hebei
    • Shijiazhuang, Hebei, China
      • The First Hospital of Hebei Medical University
      • Principal Investigator: Conghui Li
  • Henan
    • Luoyang, Henan, China
      • The First Affiliated Hospital of Henan Science & Technology University
      • Principal Investigator: Jisheng Qi
  • Hubei
    • Wuhan, Hubei, China
      • Zhongnan Hospital of Wuhan University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Drum Tower hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi Provincial People's Hospital
      • Principal Investigator: Wenfeng Cao
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
      • Principal Investigator: Shouchun Wang
  • Liaoning
    • Dalian, Liaoning, China
      • The First Affiliated Hospital of Dalian Medical University
  • Neimenggu
    • Baotou, Neimenggu, China
      • Baotou City Central Hospital
      • Principal Investigator: Changchun Jiang
  • Shandong
    • Jining, Shandong, China
      • Affiliated Hospital of Jining Medical University
      • Principal Investigator: Yongnan Hao
  • Yunnan
    • Kunming, Yunnan, China
      • First Affiliated Hospital of Kunming Medical University
      • Principal Investigator: Chun Chen
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital
      • Principal Investigator: Congguo Yin
    • Ningbo, Zhejiang, China
      • Ningbo First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intracranial Stent (Tonbridge); Placement of Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd. ).	Device: Intracranial Stent (Tonbridge); The intracranial stent consists of a self-expanding, laser-carved nickel-titanium stent and its delivery system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of in-stent restenosis at 6 months	The in-stent restenosis is defined as more than 50% stenosis within stent or distal/proximal ends (within 5 mm), and more than 20% absolute lumen loss. The degree of intracranial artery stenosis are measured qualitatively in DSA examination. WASID study will be used to measure the degree of intracranial artery stenosis.	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success rate and procedural success rate	Device success refers to the successful delivery of the stent to the lesion site through the delivery system during procedure, and it is released smoothly and fits well with the vessel wall without bending and displacement; procedural success is defined as stenosis degree less than 30% immediately after procedure.	Intraoperation
Incidence of symptomatic in-stent restenosis at 6 months, 1 year, and 2 years	Symptomatic in-stent restenosis is defined as ischemic stroke or TIA or other ischemic neurological symptoms which are caused by in-stent restenosis.	6 months, 1 year, and 2 years post-procedure
Ratio of mRS 0-2 at 30 days, 6 months, 1 year, and 2 years	Subjects will be evaluated at the follow-up visits according to the mRS. The mRS 0-2 indicates a good prognosis.	30 days, 6 months, 1 year, and 2 years post-procedure
Incidence of stent restenosis at 1 and 2 years	Restenosis is defined as more than 50% stenosis within stent or distal/proximal ends (within 5 mm), and more than 20% absolute lumen loss.	1 and 2 years post-procedure
Incidence of any stroke and death within 30 days	Stroke includes both ischemic and hemorrhagic strokes. Deaths from any cause are included in this data.	Within 30 days post-procedure
Mortality at 31 days to 6 months, 6 to 12 months, and 12 to 24 months		31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
Incidence of ischemic stroke in the target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months		31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
Incidence of ischemic stroke in non-target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months		31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
The incidence of any hemorrhagic stroke at 31 days to 6 months, 6 to 12 months, and 12 to 24 months		31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
Incidence of device deficiency	Device deficiency is the unreasonable risk that may endanger human health or life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems, malfunctions, etc. Possible device deficiency: labeling errors, product quality problems, design defects, broken sterilization packaging, etc.	After use of device to end of study
Incidence of adverse events (AE) at 30 days, 6 months, 1 year, and 2 years		Through 2 years post-procedure
Incidence of serious adverse events (SAE) at 30 days, 6 months, 1 year, and 2 years		Through 2 years post-procedure

Collaborators and Investigators

• Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Investigators: Principal Investigator: Shouchun Wang, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

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; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Atherosclerosis; Intracranial Arteriosclerosis
• Other Study ID Numbers: ZHTQ 202201

Drug and device information, study documents

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