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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Baotou City Central Hospital
RECRUITING
Baotou
The First Hospital of Jilin University
RECRUITING
Changchun
The First Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Hangzhou First People's Hospital
RECRUITING
Hangzhou
First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
The First Affiliated Hospital of Henan Science & Technology University
NOT_YET_RECRUITING
Luoyang
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
Ningbo First Hospital
RECRUITING
Ningbo
Changhai Hospital of Shanghai
NOT_YET_RECRUITING
Shanghai
Shanghai Fourth People's Hospital
RECRUITING
Shanghai
Tongji Hospitai of Tongji University
NOT_YET_RECRUITING
Shanghai
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Long Chen
long.chen@ton-bridge.com
13868091267
Backup
Yuhan Yan
yh.yan@ton-bridge.com
15843291055
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 200
Treatments
Experimental: experimental group
Intracranial Stent (Tonbridge)
Active_comparator: control group
Wingspan Stent System (Stryker Neurovascular)
Related Therapeutic Areas
Sponsors
Leads: Ton-Bridge Medical Tech. Co., Ltd

This content was sourced from clinicaltrials.gov

Similar Clinical Trials