EMBA Peripheral Embolization Device ("EPED") Study

EMBA Medical, Inc.1 site in 1 country15 target enrollmentFebruary 2015

ConditionsPeripheral Embolization

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Embolization
Sponsor: EMBA Medical, Inc.
Enrollment: 15
Locations: 1
Primary Endpoint: Target vessel occlusion (assessed by CTA)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

August 2016

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

EMBA Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.