IMPEDE and IMPEDE-FX Embolization Plug Registry
EMBO-PMS
Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs
1 other identifier
observational
108
2 countries
10
Brief Summary
EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2019
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2019
CompletedFirst Submitted
Initial submission to the registry
July 31, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedDecember 26, 2025
December 1, 2025
6.1 years
July 31, 2019
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Safety - Rate of freedom from serious adverse events
Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor
30 days
Efficacy - Rate of technical success (embolization of target vessel)
Technical success, defined as embolization of the target area after deployment of the study device
Immediately after the intervention
Secondary Outcomes (3)
Efficacy - Rate of recurrence of clinical symptoms, based on original complaint
90 days
Efficacy - Rate of treated vessel occlusion
90 days
Safety - Rate of freedom from serious adverse events
90 days
Interventions
Peripheral vascular embolization
Eligibility Criteria
Adult study participants considered candidates for a peripheral vascular embolization procedure
You may qualify if:
- Study participant is ≥18 years of age
- Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden
Dresden, 01307, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Schleswig-Holstein (Campus Kiel)
Kiel, 24105, Germany
UNIVERSITÄTSKLINIKUM LEIPZIG AöR
Leipzig, 04103, Germany
Klinikum München rechts der Isar
München, 81675, Germany
Klinikum Nürnberg
Nuremberg, 90471, Germany
Klinikum StuttGart
Stuttgart, 70174, Germany
Uniklinikum Würzburg
Würzburg, 97080, 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
Study Officials
- STUDY CHAIR
Robert Morgan, MBChB
St George's Hospital (St George's University Hospitals NHS Foundation Trust)
- STUDY CHAIR
Götz Richter
Klinikum Stuttgart
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2019
First Posted
August 5, 2019
Study Start
July 9, 2019
Primary Completion
August 30, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
December 26, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share