The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomati… (NCT05757505) | Clinical Trial Compass
RecruitingNot Applicable
The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
China200 participantsStarted 2023-05-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 t…