China Surpass Streamline Post-Market Study (NCT05544045) | Clinical Trial Compass
TerminatedNot Applicable
China Surpass Streamline Post-Market Study
Stopped: Slow Enrollment
China11 participantsStarted 2022-06-03
Plain-language summary
A multi-center, prospective, single-arm, non-randomized, post-market, observational study.
The primary objective of this study is to evaluate the long-term safety and efficacy of the Surpass Streamline Flow Diverter System (FDS) in the treatment of unruptured large and giant (≥ 10 mm) saccular wide-neck (neck width ≥ 4 mm) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm to ≤ 5.3 mm.
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
. Is located in the internal carotid artery (ICA) distribution from petrous segment up to the terminus
. Is able to be crossed with a standard 0.014" guide wire
. Has unruptured saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio \< 2) or fusiform intracranial aneurysms size ≥10 mm
. Has a vessel diameter ≥ 2.5 mm to ≤ 5.3 mm at both the proximal and distal segments where the implant will be placed 4. Subject is willing to comply with all scheduled follow-up visits and examinations per institutional standard of care
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
Primary Safety Endpoint. Percentage of subjects experiencing neurological death or major ipsilateral stroke in the treated vascular territory
Timeframe: 12 months
2
Primary Efficacy Endpoint. Percentage of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis defined as >50% stenosis of the parent artery