Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis

This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of a balloon microcatheter in the treatment of intracranial artery stenosis. A total of 56 patients are planned to be included. The endpoints include device success, target vessel dissection, target vessel occlusion, mortality and cerebrovascular events, assessed during the in-hospital until discharge.

Inclusion criteria

• 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

Exclusion criteria

• 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
• Patients with stroke caused by branch occlusion
• Patients who were participating in other clinical trials who had not yet reached the primary clinical endpoint
• Known hypersensitivity to aspirin, heparin, anesthetics and contrast agents
• Investigators consider the patient who is not suitable for enrolling in the present trial