The primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis.
18 to 80 years of age
Patients with intracranial artery stenosis (Degree of stenosis: ≥70%)
Target vessel reference diameter must be visually estimated to be 1.25 mm to 4.50 mm
Willingness to participate in this clinical trial and signing the consent form for patients or their legally authorised representatives
The proximal end of the target vessel is extremely tortuous, severely angulated, or heavily calcified, making it difficult for the device to reach the target vessel
Pre-existing severe respiratory, hepatic, or renal diseases (e.g., creatinine ≥ 3.0 mg/dL) or coagulation disorders
Disabling stroke with a baseline mRS score ≥ 3 points
Non-atherosclerosis diseases
Single group
balloon microcatheter
DeviceThe balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions.
Rate of device success
The system was successfully delivered to the target site, the balloon was successfully inflated at the lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn.
Incidence of cerebrovascular events, including transient ischemic attack (TIA), ischemic stroke, and hemorrhagic stroke.
Rate of target vessel dissection, target vessel occlusion
Number of patients with dissection or occlusion of the target vessel
Mortality
The proportion of patients who died during the in-hospital until discharge
Proportion of adverse events or severe adversary event
The proportion of adverse events or severe adverse event
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