China Surpass Streamline Post-Market Study

Aneurysm, Intracranial Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Intracranial
• Intracranial Aneurysm

• NCT number: NCT05544045
• Study type: Observational
• Source: Stryker Neurovascular
• Status: Terminated
• Start date: June 3, 2022
• Completion date: September 30, 2023