Surpass Evolve Flow Diverter System
DeviceEndovascular treatment with Surpass Evolve Flow Diverter System was performed in patients diagnosed with intracranial aneurysms
NCT Number: NCT06368622
A prospective, multi-center, single-arm, open-label, observational, post-market clinical follow-up. The expected duration of the study is 8 years (including up to 5-years' follow-up). Each subject will be followed up per standard of care (SoC) at each study site.
This study is active but is not currently recruiting participants.
18 year–80 year
All sexes
Observational
Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
*If the subject becomes pregnant during her participation, the physician will have to evaluate the risk associated to her continuing participation to the rest of the study.
Endovascular treatment with Surpass Evolve Flow Diverter System was performed in patients diagnosed with intracranial aneurysms
Time frame: 12 months (-3/ +6 months) post-procedure
Neurological death or disabling stroke at 12 months post-procedure (-3/ + 6 months).
Time frame: 12 months (-3/+6 months) post-procedure
A composite of 100% occlusion (defined as Raymond-Roy class 1) of the target aneurysm without significant parent artery stenosis (significant stenosis defined as ˃50% stenosis), per the assessment of images required, and with no retreatment of target aneurysm at 12 months (-3/+6 months) post-procedure.
Time frame: 60 months
Procedure- and device-related serious adverse events through 60 months post-procedure
Time frame: 60 months
Key neurological events of interest through 60 months post-procedure
Time frame: Intraprocedural
Delivery and deployment of one or more study devices to completely cover the neck of the target aneurysm in an individual subject.
Time frame: Intraprocedural
Delivery and deployment of a study device to completely cover the neck of the target aneurysm, either alone or in conjunction with another Surpass Evolve FDS.
Time frame: Intraprocedural
Successful re-sheathing with single attempt.
Stryker Neurovascular
Industry
A Post-Market Clinical Follow-up Study to Evaluate the Long-Term Safety and Effectiveness of Surpass Evolve Flow Diverter System
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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