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EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill | Device | Peripheral vascular embolization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Rate of recurrence of clinical symptoms, based on original complaint | Number of participants free of recurrent clinical symptoms, based on clinical symptoms of original complaint | 90 days |
| Efficacy - Rate of treated vessel occlusion |
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Inclusion Criteria:
Exclusion Criteria:
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Adult study participants considered candidates for a peripheral vascular embolization procedure
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| Name | Affiliation | Role |
|---|---|---|
| Robert Morgan, MBChB | St George's Hospital (St George's University Hospitals NHS Foundation Trust) | Study Chair |
| Götz Richter | Klinikum Stuttgart | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden | Dresden | 01307 | Germany | |||
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Treated vessel occlusion, measured per study site standard of care for the original condition treated
| 90 days |
| 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 | 90 days |
| 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 |