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NCT Number: NCT04044443

IMPEDE and IMPEDE-FX Embolization Plug Registry

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Peripheral Vascular Embolization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden, Dresden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill

Device

Peripheral vascular embolization

Primary outcomes

  1. Safety - Rate of freedom from serious adverse events

    Time frame: 30 days

    Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor

  2. Efficacy - Rate of technical success (embolization of target vessel)

    Time frame: Immediately after the intervention

    Technical success, defined as embolization of the target area after deployment of the study device

Secondary outcomes

  1. Efficacy - Rate of recurrence of clinical symptoms, based on original complaint

    Time frame: 90 days

    Number of participants free of recurrent clinical symptoms, based on clinical symptoms of original complaint

  2. Efficacy - Rate of treated vessel occlusion

    Time frame: 90 days

    Treated vessel occlusion, measured per study site standard of care for the original condition treated

  3. Safety - Rate of freedom from serious adverse events

    Time frame: 90 days

    Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor

Sponsors and collaborators

Lead sponsor

Shape Memory Medical, Inc.

Industry

Registry information

Official study title

Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs

Acronym: EMBO-PMS

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2019
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.