Status:

ACTIVE_NOT_RECRUITING

IMPEDE and IMPEDE-FX Embolization Plug Registry

Lead Sponsor:

Shape Memory Medical, Inc.

Conditions:

Peripheral Vascular Embolization

Eligibility:

All Genders

18+ years

Brief Summary

EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems

Eligibility Criteria

Inclusion

  • Study participant is ≥18 years of age
  • Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature

Exclusion

  • Study participant has an inability to provide written informed consent
  • Study participant/treatment outside of the approved study device labeling, instructions for use (IFU)
  • Study participant is a prisoner or member of other vulnerable population

Key Trial Info

Start Date :

July 9 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2026

Estimated Enrollment :

108 Patients enrolled

Trial Details

Trial ID

NCT04044443

Start Date

July 9 2019

End Date

September 1 2026

Last Update

December 26 2025

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden

Dresden, Germany, 01307

2

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

3

Universitätsklinikum Schleswig-Holstein (Campus Kiel)

Kiel, Germany, 24105

4

UNIVERSITÄTSKLINIKUM LEIPZIG AöR

Leipzig, Germany, 04103