EMBA Peripheral Embolization Device (EPED) Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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EMBA Peripheral Embolization Device (EPED) Study

Conditions
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Peripheral Embolization

Intervention / Treatment
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* Device: The EMBA Peripheral Embolization Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is >18 years of age. Patient is considered a candidate for arterial or venous embolization in the peripheral vasculature. Patient has a target vessel diameter of 3-8mm and a target PED landing zone of greater than 25mm wherein the vessel diameter is between 3 and 8 mm. The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent. The patient has suitable vessel anatomy that would allow proper placement of the PED. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm - EMBA PED<br>The EMBA Peripheral Embolization Device when indicated for arterial and venous embolization in the peripheral vasculature. | Device: The EMBA Peripheral Embolization Device<br>* arterial and venous embolization in the peripheral vasculature<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel occlusion (assessed by CTA) | vessel occlusion as assessed by CTA | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic, Embolization