IMPEDE and IMPEDE-FX Embolization Plug Registry

NCT04044443 · tracked via the Priya Life Science UK tracker

Sponsor

Shape Memory Medical, Inc.

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

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)

Facility	City	Region
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

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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