Clinical Trials in the UK / NCT04044443
Active, not recruiting
Observational
IMPEDE and IMPEDE-FX Embolization Plug Registry
NCT04044443 · tracked via the Priya Life Science UK tracker
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
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 | Status |
|---|---|---|---|
| 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