EMBA Peripheral Embolization Device ("EPED") Study

EMBA Medical

Status: Completed

Conditions: Peripheral Embolization

Treatments: Device: The EMBA Peripheral Embolization Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02335788

PRT-EPE-0028

Details and patient eligibility

About

This is an open label, acute, non-randomized, prospective, "first in man" (FIM) single-center study of the EMBA Medical Peripheral Embolization Device (PED).

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient is >18 years of age.
2. Patient is considered a candidate for arterial or venous embolization in the peripheral vasculature.
3. 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.
4. 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.
5. The patient has suitable vessel anatomy that would allow proper placement of the PED.

Exclusion criteria

1. 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

2. The patient has an uncontrolled infectious disease.

3. The patient has a life expectancy of less than 6 months.

4. The patient is pregnant.

5. The patient has a condition that inhibits radiographic visualization of the PED.

6. The patient has a known allergy or intolerance to Nitinol.

7. The patient has a known hypersensitivity to contrast that cannot be pre-treated.

8. The patient's access vessels preclude safe insertion of the delivery system.

9. The patient is currently participating in another device or drug study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Single arm - EMBA PED

Other group

Description:

The EMBA Peripheral Embolization Device when indicated for arterial and venous embolization in the peripheral vasculature.

Treatment:

Device: The EMBA Peripheral Embolization Device