Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneur… (NCT06303063) | Clinical Trial Compass
CompletedNot Applicable
Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms
China203 participantsStarted 2024-01-17
Plain-language summary
The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary efficacy endpoint is complete aneurysm occlusion without retreatment or significant parent artery stenosis at 12 months post-procedure
Timeframe: 12 months post-procedure
2
The primary safety endpoint is the incidence of major ipsilateral stroke or neurogenic death within 12 months post-procedure
. 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.