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.
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;
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;
Parallel
Intracranial Stent (Tonbridge)
DeviceEndovascular treatment with Intracranial Stent (Tonbridge).
Wingspan Stent System (Stryker Neurovascular)
DeviceEndovascular treatment with Wingspan Stent System (Stryker Neurovascular).
Incidence of any stroke and death within 30 days
Stroke includes both ischemic and hemorrhagic stroke. Death includes death due to any cause.
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.
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