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

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<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.