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China Surpass Streamline Post-Market Study

NCT05544045 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2025-02-07

No results posted yet for this study

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.

Conditions

  • Aneurysm, Intracranial

Interventions

DEVICE

Surpass Streamline Flow Diverter System

The Surpass Streamline FDS is indicated for use in the endovascular treatment of adults (age 18 years or older) with unruptured large (≥ 10 mm) saccular, wide-neck (neck width ≥ 4 mm or dome/neck ratio \< 2 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.

Sponsors & Collaborators

  • Stryker (Beijing) Healthcare Products Co., Ltd

    collaborator INDUSTRY

  • Stryker Neurovascular

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-03
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05544045 on ClinicalTrials.gov