Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Biolimus-coated Intracranial Balloon Dilation Catheter Treatment of Patients With Symptomatic Intracranial Atherosclerotic Stenosis

This test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of Biolimus coating. After completing the follow-up 6 months after the operation, a clinical summary report was issued for the registration application of the product, and on this basis, 12 months of postoperative follow-up was carried out to evaluate the mid-term curative effect.

Inclusion Criteria:

• 18 to 80 years old;
• Symptomatic intracranial artery stenosis, and the degree of visual stenosis of target blood vessels under intracranial angiography is 70~99%(WASID method);

Exclusion Criteria:

• Target blood vessels are seriously calcified and distorted, and it is difficult to put the interventional instruments in place or recover;
• Ischemic cerebral infarction occurred 3 weeks before surgery;
• Cerebral hemorrhage 3 months before operation;