Peripheral Vascular Embolization Clinical Trial
— EMBO-PMSOfficial title:
Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs
| NCT number | NCT04044443 |
| Other study ID # | CRD1012 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 9, 2019 |
| Est. completion date | June 2025 |
EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems
| Status | Recruiting |
| Enrollment | 125 |
| Est. completion date | June 2025 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | 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 | Nürnberg | |
| Germany | Klinikum StuttGart | Stuttgart | |
| Germany | Uniklinikum Würzburg | Würzburg | |
| United Kingdom | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Shape Memory Medical, Inc. |
Germany, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | Efficacy - Rate of treated vessel occlusion | Treated vessel occlusion, measured per study site standard of care for the original condition treated | 90 days | |
| Secondary | 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 |