Bleeding, Trauma Injury
Conditions
Brief summary
This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.
Interventions
DEVICEMicro Plug Set
The Micro Plug Set is indicated for arterial embolization in the peripheral vasculature.
Sponsors
Merit Medical Systems, Inc.
KA Medical, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is scheduled for arterial embolization in the peripheral vasculature. * Subject is greater than 18 years of age
Exclusion criteria
* Subject is unable to give informed consent * Subject is pregnant or breastfeeding * Subject has allergy to nickel * Patient requires neurologic or cardiac use of an occlusion device, contrary to the Micro Plug Set Instructions For Use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of serious device-related and procedure-related adverse events | 12 months | Rate of serious device-related and procedure-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful delivery of the device | 1 day | Rate of successful delivery of the Micro Plug device to the intended position. |
Countries
Germany
Outcome results
None listed