ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis

Inclusion Criteria:

• 18 to 80 years of age

• Confirmed by DSA: in-stent restenosis (ISR) at intracranial segment of internalcarotid artery, middle cerebral artery, basilar artery and vertebral artery; ISR isdefined as >50% stenosis within or immediately adjacent (within 5 mm) of theimplanted stent and >20% absolute luminal loss

• presence of ISR associated ischemic stroke or transient ischemic attacks even withmedical treatment and strict control of risk factor

• asymptomatic ISR with severe hypoperfusion in the ISR territories, confirmed by acerebral blood flow decrease of ≥30% when compared with the perfusion on thecontralateral side for anterior circulation lesions or the anterior circulationterritory for posterior circulation lesions on CT perfusion, and/or by an AmericanSociety of Interventional and Therapeutic Neuroradiology/Society of InterventionalRadiology (ASITN/SIR) Collateral Flow Grading System score <3 on DSA.

• the diameter of target vessel is 2.0-4.5mm

• there is only one intracranial ISR lesion per subject

• 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;

• any history of brain parenchyma or other intracranial subarachnoid, subdural orextradural 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 asNIHSS score increased by ≥ 4 points over the baseline)

• patients with thrombus in target vessels.

• in addition to ISR lesions, there are other primary intracranial lesions that needendovascular treatment.

• Major surgery (including open femoral, aortic or carotid artery surgery) is plannedwithin the past 30 days or within 90 days.

• patients with renal artery, iliac artery and cardiac coronary artery requiringsimultaneous intervention.

• Combined with intracranial tumors, aneurysms or intracranial arteriovenousmalformations.

• Cardiac stroke or potential cardiogenic thromboembolism, with any of the followingcardiogenic embolism causes: chronic or paroxysmal atrial fibrillation, mitral valvestenosis, mechanical valves, endocarditis, intracardiac thrombus or implant, dilatedcardiomyopathy, 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 heart, lung andother important organs.

• patients with known severe hepatic and renal dysfunction.

• patients with hemoglobin < 100g / L, platelet count < 100,000 / mm3, INR > 1.5orwith uncorrectable factors leading to bleeding.

• patients who cannot receive dual antiplatelet therapy due to existing diseases orwho are tested to be tolerant to dual antiplatelet therapy.

• 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 bloodpressure > 180mmHg or diastolic blood pressure > 110mmHg).

• Life expectancy < 1 year.

• pregnant or lactating women.

• patients who are unable to complete follow-up due to cognitive, emotional disordersor mental illness.

• Patients who are participating in other drug/device clinical trials and have notcompleted all follow-ups required by the programme;

• According to the judgement of the investigator, other situations that are notsuitable for enrollment