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Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System

NCT04195568 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2026-04-09

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches

Conditions

  • Aneurysm, Intracranial

Interventions

DEVICE

Surpass Evolve Flow Diverter System

The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤12 mm.

Sponsors & Collaborators

  • Stryker Neurovascular

    lead INDUSTRY

Principal Investigators

  • Adam S Arthur, MD · Semmes Murphy Clinic

  • Vitor M Pereira, MD · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2025-07-14
Completion
2028-09-13
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada

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 NCT04195568 on ClinicalTrials.gov