Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms

This study is a prospective, multicenter, 1:1 randomized clinical trial to evaluate the safety and efficacy of stent system in the treatment of intracranial aneurysms. A total of 204 patients are planned to be included. The primary efficacy endpoint is complete aneurysm occlusion without retreatment or significant parent artery stenosis at 12 months post-procedure. The primary safety endpoint is the incidence of major ipsilateral stroke or neurogenic death within 12 months post-procedure. All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Inclusion criteria

• Age 18 years to 80 years.
• Wide-necked (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio < 2), saccular, intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 5mm.
• Modified Rankin Scale (mRS) ≤ 2.
• Subject understands the nature of the procedure, provides voluntary written informed consent prior to the treatment, and is willing to comply with specified follow-up evaluation.
• The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm.

Exclusion criteria

• Target aneurysm is an aneurysm requiring staged procedure.
• Target aneurysm that has been previously treated with vascular embolization or surgery.
• Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations.
• Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery.
• Acutely ruptured aneurysm within 14 days of enrollment.
• Hunt and Hess (H&H) scale ≥3.
• Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms.
• Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device.
• Platelet count <50*103/mm3 (50*109/L) or any known coagulation deficiency, or International normalized ratio (INR)>3.0.
• Known hypersensitivity/allergies or contraindication to contrast media, stent components, antiplatelets, anticoagulants.
• Life expectancy < 1 year, and unable to complete the required follow-ups;
• Female who was pregnant or breastfeeding, women/men planning to havve children in the next year.
• Currently enrolled in another investigational device or drug study.