AcoArt sICAS: DCB in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

Exclusion Criteria

• •Patients with stroke within 2 weeks before procedure;
• •Patients with stroke caused by perforating artery occlusion;
• •Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 30 days;
• •Those who have received thrombolysis within 24 hours before procedure;
• •Deterioration of neurological function within 24 hours before procedure (defined as NIHSS score increased by ≥ 4 points over the baseline);
• •The vascular path showed in angiography is so tortuous that it is difficult to advance catheters to the target lesion or retrieve;
• •Lesions that investigators believe are not suitable for stenting;
• •Patients with thrombus in target vessel;
• •In addition to the target lesion, there are still other de novo lesion or ISR lesion with more than 70% diameter stenosis in intracranial arteries that need to be treated at the same time;
• •After endovascular treatment of the target lesion, there is still a stenosis of more than 50% in the main blood supplying artery or an obstructive lesion in the distal vessel of target lesion;
• •Major surgery (including open femoral artery, aortic or carotid artery surgery) within the past 30 days or planned within 90 days;
• •Patients with renal artery, iliac artery, and coronary artery requiring simultaneous intervention;
• •Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation;
• •Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, moya-moya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any Other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected Vasospasm, suspicious embolism recanalization, etc.;
• •Cardiac stroke or potential cardiogenic thromboembolism, with any of the following cardiogenic embolism causes: chronic or paroxysmal atrial fibrillation, mitral valve stenosis, mechanical valves, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, spontaneous acoustic imaging of the left atrium;
• •Patients with myocardial infarction within 6 weeks before procedure;
• •Those who cannot tolerate general anesthesia due to insufficiency of important organs such as heart and lungs;
• •Patients with known severe hepatic and renal dysfunction;
• •Patients with hemoglobin\<100g/L, platelet count\<100×1,000,000,000/L, INR\>1.5 or there are uncorrectable factors leading to bleeding(if there are multiple checks, the last one shall prevail);
• •Patients who cannot receive dual antiplatelet therapy due to existing diseases or are tolerant to dual antiplatelet therapy confirmed by relevant test;
• •Patients with known severe allergies or contraindications to heparin, paclitaxel, contrast agents and other related intravascular treatment drugs;
• •Current alcohol or drug abuse, uncontrolled severe hypertension (systolic blood pressure\>180mmHg or diastolic blood pressure\>110mmHg);
• •Life expectancy \<1 year;
• •Pregnant or lactating women;
• •Patients who cannot complete the follow-up due to cognitive, emotional or mental illness;
• •Patients who are participating in other drug/device clinical trials and have not completed all follow-ups required by the programmer;
• •According to the judgement of the investigator, other situations that are not suitable for enrollment.