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Active, not recruiting Observational

IMPEDE and IMPEDE-FX Embolization Plug Registry

NCT04044443 · tracked via the Priya Life Science UK tracker
Phase
Observational
Started
2019-07-09
Last updated
2025-12-26

Condition(s) studied

Peripheral Vascular Embolization

Investigational drug(s) / intervention(s)

IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill

IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill: Peripheral vascular embolization

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Safety - Rate of freedom from serious adverse events — 30 days
    Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor
  • Efficacy - Rate of technical success (embolization of target vessel) — Immediately after the intervention
    Technical success, defined as embolization of the target area after deployment of the study device

Trial sites (10)

FacilityCityRegionStatus
Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden Dresden Germany
Universitätsklinikum Heidelberg Heidelberg Germany
Universitätsklinikum Schleswig-Holstein (Campus Kiel) Kiel Germany
UNIVERSITÄTSKLINIKUM LEIPZIG AöR Leipzig Germany
Klinikum München rechts der Isar München Germany
Klinikum Nürnberg Nuremberg Germany
Klinikum StuttGart Stuttgart Germany
Uniklinikum Würzburg Würzburg Germany
St George's Hospital (St George's University Hospitals NHS Foundation Trust) London United Kingdom
St Mary's Hospital (Imperial College Healthcare NHS Trust) London United Kingdom

More Shape Memory Medical, Inc. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04044443 on ClinicalTrials.gov ↗ ← All trials in the UK