Phase
Condition
Claudication
Stent
Treatment
Wingspan stent system
Clinical Study ID
Ages 30-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
30 to 80 years of age;
Patients with symptomatic intracranial atherosclerotic stenosis who failedantiplatelet therapy or poor collateral circulation compensation or hypoperfusion inthe territory of the culprit artery;
Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in targetintracranial artery;
The target lesion was in the internal carotid artery (intracranial segment), middlecerebral artery, vertebral artery (intracranial segment), basilar artery, and it wasa single lesion that required surgical treatment;
The patient voluntarily underwent treatment with the Wingspan stent system;
mRS < 3 (if any);
The onset of the latest transient ischemic attack (TIA) was not limited or ischemicstroke occurred within 2 weeks prior to stenting procedure;
Willingness to participate in this clinical trial and signing the consent form, andbe able to complete the corresponding inspections, follow ups, etc. according to therequirements of the clinical protocol during the clinical trial.
Exclusion
Exclusion Criteria:
The target vessels was complete occlusion;
>70% stenosis observed at the intracranial large-vessel distal to the target vesselor >70% stenosis observed at the intracranial/extracranial large-vessel proximal tothe target vessel;
Preoperative magnetic resonance showed perforating infarction in the target lesionarea;
Preoperative CT showed that there was hemorrhage transformation after infarction inthe target vessel area, or a history of primary cerebral hemorrhage, or a history ofsubarachnoid, subdural and epidural hemorrhage within 30 days before operation, orthere was no treatment Chronic subdural hematoma ≥5mm;
Hospitalized surgical treatment within 30 days before operation, or plannedhospitalized surgical treatment within 6 months after surgery;
CT showed Severe calcified lesions;
Previously received endovascular treatment or surgical intervention at the targetvessel (except for patients with simple balloon dilatation);
Non-atherosclerosis lesions;
Patients with potential sources of cardiac embolism (such as atrial fibrillation,left ventricular thrombosis, myocardial infarction within 6 weeks);
Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;
Known hypersensitivity to aspirin, heparin, clopidogrel, rapamycin (sirolimus),lactic acid polymer, poly-n-butyl methacrylate, nickel-titanium alloy, orcontraindications to anesthetics and contrast agents;
Hemoglobin <100g/L, platelet count <100*109/L, International normalized ratio (INR) >1.5 (irreversible) or uncorrectable hemorrhagic factors;
Uncontrollable severe hypertension (systolic blood pressure>180 millimetres ofmercury (mmHg) or diastolic blood pressure>110mmHg);
Known liver or renal insufficiency (aspartate transaminase (ALT)> 3x upper limit oraspartate transaminase > 3x upper limit, Serum creatinine#250μmol/L);
Life expectancy < 1 year;
Pregnant/lactating female patients;
Patients with cognitive impairment or mental diseases (except for those withcognitive impairment due to arterial stenosis);
Patients who were participated in other clinical trials within 3 months orparticipating in other clinical trials who had not yet reached the primary clinicalendpoint.
Study Design
Study Description
Connect with a study center
The First People's Hospital of Changzhou
Changzhou, Jiangsu
ChinaSite Not Available

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