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

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the SINOMED IAS for the Treatment of Intracranial Aneurysms

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with 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:

1. Age 18 years to 80 years.
2. 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.
3. Modified Rankin Scale (mRS) ≤ 2.
4. 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.
5. The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm.

Exclusion Criteria:

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