Comparing two stent systems for treating brain aneurysms

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

This study is testing two different stent systems to see which one works better for treating brain aneurysms in patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sinomed Neurovita Technology Inc. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06303063 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of two different stent systems, SINOMED IAS and Neuroform Atlas, in treating wide-necked intracranial aneurysms. It is a prospective, multicenter, randomized study involving 204 patients, with the primary goal of assessing the success of aneurysm occlusion six months after the procedure. Participants will undergo clinical follow-ups at various intervals, including intraoperative, 30 days, 6 months, and 1 year post-treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with specific types of wide-necked saccular intracranial aneurysms.

Not a fit: Patients with previously treated aneurysms or those with certain complex aneurysm types will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with wide-necked intracranial aneurysms.

How similar studies have performed: Previous studies have shown varying success with stent-assisted treatments for intracranial aneurysms, making this approach both relevant and potentially beneficial.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Jianxin Yang — Beijing Tiantan Hospital
• Study coordinator: Aihua Liu

Conditions Intracranial Aneurysm; wide-necked cerebral aneurysms; Brain Aneurysm; Cerebral Aneurysm; Stent