Peripheral Vascular Embolization
Conditions
Brief summary
EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems
Interventions
DEVICEIMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill
Peripheral vascular embolization
Sponsors
Shape Memory Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Rate of recurrence of clinical symptoms, based on original complaint | 90 days | Number of participants free of recurrent clinical symptoms, based on clinical symptoms of original complaint |
| Efficacy - Rate of treated vessel occlusion | 90 days | Treated vessel occlusion, measured per study site standard of care for the original condition treated |
| Safety - Rate of freedom from serious adverse events | 90 days | Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor |
Countries
Germany, United Kingdom
Outcome results
None listed