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This is an open label, acute, non-randomized, prospective, "first in man" (FIM) single-center study of the EMBA Medical Peripheral Embolization Device (PED).
This study is a FIM, open label, prospective, single center, non-randomized, evaluation of the EMBA Medical Peripheral Embolization Device (PED) used for arterial or venous embolization in the peripheral vasculature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm - EMBA PED | Other | The EMBA Peripheral Embolization Device when indicated for arterial and venous embolization in the peripheral vasculature. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The EMBA Peripheral Embolization Device | Device | arterial and venous embolization in the peripheral vasculature |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel occlusion (assessed by CTA) | vessel occlusion as assessed by CTA | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
The patient has one of the following conditions:
1.1 Arterio-venous fistula 1.2 Hypercoagulability 1.3 Systemic coagulopathy 1.4 Connective tissue disorder such as Ehlers-Danlos Syndrome 1.5 Congenital arteritis such as Takayasu's Disease 1.6 Other circulatory disorders at the discretion of the implanting physician
The patient has an uncontrolled infectious disease.
The patient has a life expectancy of less than 6 months.
The patient is pregnant.
The patient has a condition that inhibits radiographic visualization of the PED.
The patient has a known allergy or intolerance to Nitinol.
The patient has a known hypersensitivity to contrast that cannot be pre-treated.
The patient's access vessels preclude safe insertion of the delivery system.
The patient is currently participating in another device or drug study.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Holden, MD | Auckland City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland City Hospital | Grafton | Auckland | 1023 | New Zealand |
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