NCT05544045

China Surpass Streamline Post-Market Study

Endovascular Treatment of Patients in China With the Surpass Streamline Flow Diverter for Unruptured Large and Giant Saccular Wide-Neck or Fusiform Intracranial Aneurysms in the Internal Carotid Artery

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Stryker Neurovascular · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Aneurysm, Intracranial

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-03
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-09-16
• Last updated: 2025-02-07

Locations

15 sites across 1 country: China