acoart sicas: dcb in the treatment of symptomatic intracranial atherosclerotic stenosis

Conditions: Intracranial Atherosclerosis; Stroke

Summary: the purpose of the rct trial is to determine whether dcb is not inferior to stent in treating intracranial stenosis.

this trial is a prospective, multi-center, 1:1 randomized using paclitaxel coated balloon versus stent to treat intracranial stenosis of 70-99% degree. and primary endpoint is angiographic restenosis at 6 months post-procedure.

Eligibility criteria:
inclusion criteria: * 18 to 80 years of age; * patients with symptomatic intracranial atherosclerotic stenosis; * patients with intracranial arterial de novo stenosis confirmed by digital subtraction angiography (dsa); * confirmed by dsa，the diameter of the target vessel is between 2.5mm-4.5mm ; according to wasid method, the degree of stenosis of the target lesion is 70%-99%; * baseline mrs score ≤2; * voluntarily participate in this study and sign the informed consent form. 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\ 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.

Keywords: intracranial atherosclerosis stroke drug coated balloon