Bioabsorbable/Nufairy Coil Application Trial in China

Exclusion Criteria

• •1. mRS Score ≥3 points in clinical assessment prior to enrollment;
• •2. Subjects who received neurosurgical or endovascular treatment for recurrent aneurysms;
• •3. Subjects with multiple aneurysms;
• •4. Subjects with ruptured aneurysms \<30 days;
• •5. Significant stenosis (≥50%) of parent artery;
• •6. Subjects who are not suitable for anesthesia or intravascular surgery, such as major diseases of the heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, and a history of serious mental illness;
• •7. Subjects who have undergone major surgical procedures (such as internal fixation device implantation of limbs fracture, tumor resection, major organ surgery, etc.) within 30 days before signing the informed consent or plan to undergo major surgical procedures within 60 days after signing the informed consent;
• •8. Subjects with morphology or lesions that may interfere with device use, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, limited vascular access (e.g., severe intracranial vessel tortuosity, severe intracranial vessel spasm that does not respond to medical treatment, other anatomical or clinical changes that impede device access;
• •9. Treatment contrainidations of coils, including but not limited to: contrainidations of digital subtraction angiography, allergy to or intolerance of contrast agents, allergy to or intolerance of anti-platelet and anticoagulant drugs required for treatment, platinum-tungsten alloy, and poly(co-glycolic acid) (PLGA);
• •10. Pregnant or lactating women;
• •11. Life expectancy is less than 18 months;
• •12. Subjects participating in other drug or device studies did not meet the endpoint.