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International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach

NCT04572230 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 405

Last updated 2025-08-07

No results posted yet for this study

Summary

IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.

Conditions

  • Intracranial Aneurysm

Interventions

DEVICE

Endovascular treatment of intracranial aneurysms using a flow-diverting stent

The flow diverter brings about a reduction of blood flow to the aneurysm, which progresses over time into forming a stable thrombus within the aneurysm, as well as eventual aneurysm scarring and retraction. The flow diverter also acts as a scaffold for tissue growth across the neck of the aneurysm, which blocks the aneurysm from the artery blood flow.

Sponsors & Collaborators

  • Stryker Neurovascular

    lead INDUSTRY

Principal Investigators

  • Zsolt Kulcsár, PhD., MD · Universitätsspital Zürich, Klinik für Neuroradiologie

  • Jean-Christophe Gentric, PhD., MD · CHU Cavale Blanche Brest

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2024-10-24
Completion
2025-08-31

Countries

  • Austria
  • Finland
  • France
  • Germany
  • Italy
  • Switzerland
  • United Kingdom

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 NCT04572230 on ClinicalTrials.gov