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Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study

NCT05027698 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2022-09-26

No results posted yet for this study

Summary

The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site. This study is conducted in real-world subjects according to the FemoSeal™ VCS instruction for use (IFU), as part of the study device post-market clinical follow up surveillance plan and prospective clinical evidence collection.

Conditions

  • Vascular Closure
  • Endovascular Procedure
  • Hemostasis
  • Peripheral Vascular Disease

Sponsors & Collaborators

  • Terumo Europe N.V.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-27
Primary Completion
2022-07-04
Completion
2022-08-03

Countries

  • Belgium
  • France
  • Germany

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 NCT05027698 on ClinicalTrials.gov