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

NCT05593224 | Unknown

• 1 other identifier: ZHTQ 202201
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Intracranial Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Device success rate and procedural success rate

  Intraoperation

• Incidence of symptomatic in-stent restenosis at 6 months, 1 year, and 2 years

  6 months, 1 year, and 2 years post-procedure

• Ratio of mRS 0-2 at 30 days, 6 months, 1 year, and 2 years

  30 days, 6 months, 1 year, and 2 years post-procedure

• Incidence of stent restenosis at 1 and 2 years

  1 and 2 years post-procedure

• Incidence of any stroke and death within 30 days

  Within 30 days post-procedure

Study Arms (1)

Intracranial Stent (Tonbridge)

EXPERIMENTAL

Placement of Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd. ).

Device: Intracranial Stent (Tonbridge)

Interventions

Intracranial Stent (Tonbridge) DEVICE

The intracranial stent consists of a self-expanding, laser-carved nickel-titanium stent and its delivery system.

Intracranial Stent (Tonbridge)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ton-Bridge Medical Tech. Co., Ltd: lead

Study Sites (14)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The First Affiliated Hospital of Henan Science ＆ Technology University

Luoyang, Henan, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Baotou City Central Hospital

Baotou, Neimenggu, China

Location

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

Ningbo First Hospital

Ningbo, Zhejiang, China

Location

Changhai Hospital of Shanghai

Shanghai, China

Location

Tongji Hospitai of Tongji University

Shanghai, China

Location

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianmin Liu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Shouchun Wang

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Long Chen

CONTACT

13868091267; long.chen@ton-bridge.com

Yuhan Yan

CONTACT

15843291055; yh.yan@ton-bridge.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: May 1, 2025
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

CN (14)