intracranial atherosclerotic stenosis
Conditions
Interventions
Test Group:Treatment of symptomatic intracranial atherosclerotic stenosis using a self-expanding intracranial drug-eluting stent system.
Control Group:Treatment of symptomatic intracranial atherosclerotic stenosis using the Wingspan Stent System.
Sponsors
THE FIRST AFFILIATED HOSPITAL OF USTC ANHUI PROVINCIAL HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 18 to 80 years of age (both 18 and 80 years of age); 2) Symptomatic intracranial atherosclerotic stenosis with a degree of stenosis of the diseased intracranial artery between 70-99% as measured by cerebral angiography (WASID method) or the presence of areas of hypoperfusion as confirmed by CTP; 3)mRS =3; 4) Willing to participate in this clinical trial and voluntarily sign the informed consent form, and able to complete the appropriate examinations and follow-up visits, etc. during the clinical trial in accordance with the requirements of the clinical protocol; 5) Inclusion criteria for angiography (all must be met); a) Target lesions are located in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery; b) Visual inspection of the lesion reference diameter >2.0mm, diameter =5mm, length =34mm.
Exclusion criteria
Exclusion criteria: 1) Acute ischaemic stroke or major surgery within 2 weeks prior to enrolment; 2) Acute myocardial infarction within 4 weeks prior to enrolment; 3) Patients with a potential source of myocardial embolism prior to enrolment (e.g., atrial fibrillation, left ventricular thrombosis, myocardial infarction); 4) Intracranial haemorrhage (parenchymal haemorrhage, subarachnoid haemorrhage, subdural/extracranial haemorrhage) within 3 months prior to enrolment; 5) History of gastrointestinal bleeding within 6 months prior to enrolment, making antiplatelet therapy difficult; 6) Hypertension (systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg) that is uncontrollable with medication; 7) Patients with known hypersensitivity to heparin, sirolimus (rapamycin) and its derivatives, fluorinated polymers (copolymer of vinylidene fluoride and hexafluoropropylene), n-butyl methacrylate, nickel-titanium alloys, contrast media, aspirin and clopidogrel, and anaesthetics; 8) Stenosis not caused by atherosclerosis: e.g., arterial entrapment, smoldering disease (moya-moya), vasculitis, active arteritis; 9) Target lesions with prior stenting 10) Serious co-morbidities or unstable conditions, such as severe heart failure, lung failure, or renal failure (serum creatinine > 3.0 mg/dL (264 µmol/L)), severe hepatic insufficiency (ALT or AST more than 3 times the normal value), coagulation dysfunction (haemoglobin ?100g/L, platelet count ?70*109/L, International Normalised Ratio (INR) ) > 1.5 (irreversible) or uncorrectable bleeding factors), malignant tumours; 11) Patients with cognitive impairment or mental illness (except those with cognitive impairment due to arterial stenosis); 12) women who are pregnant or breastfeeding, or who are planning to become pregnant within one year; 13) Life expectancy less than 1 year; 14) Those who are participating in a clinical trial of another drug or device within the last 1 month; 15) Any other condition for which the investigator considers the patient to be unsuitable for enrolment; 16) Those with any of the following conditions on cerebral angiography: a) Two or more tandem stenotic lesions in the target vessel; and the degree of stenosis is greater than or equal to 70%. b) In addition to the target lesion, other >70% primary or restenotic (ISR) lesions of the intracranial aorta that require concurrent treatment remain; c) Combination of intracranial tumour, intracranial aneurysm or intracranial arteriovenous malformation; d) Imaging showing a tortuous path of the target vessel or other reasons that would make it difficult for the test device to reach the target location or difficult to retrieve; e) Severe calcified lesions and angulated lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month postoperative target lesion restenosis rate Input only one outcomes name; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of stroke (including recurrent ischaemic stroke or TIA) in the region of the target vessel's blood supply;Incidence of stroke (including recurrent ischaemic stroke or TIA) in non-target vessel supply regions;Incident rate of postoperative stroke (including recurrent ischaemic stroke or TIA);National Institutes of Health Stroke Scale (NIHSS) Assessment;Assessment of mRS scales;All-cause mortality;Target lesion revascularisation rate (TLR);Incidence of any stroke or death;Incidence of any haemorrhagic stroke; | — |
Countries
China
Contacts
Public ContactWei Hu
THE FIRST AFFILIATED HOSPITAL OF USTC ANHUI PROVINCIAL HOSPITAL
Outcome results
None listed