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 range18 Years – 80 Years

SexALL

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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

What they're measuring

Primary Safety Endpoint. Percentage of subjects experiencing neurological death or major ipsilateral stroke in the treated vascular territory

Timeframe: 12 months

Primary Efficacy Endpoint. Percentage of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis defined as >50% stenosis of the parent artery

Timeframe: 12 months

Trial details

NCT IDNCT05544045

SponsorStryker Neurovascular

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Aneurysm, Intracranial trials