Peripheral Embolization
Conditions
Keywords
Therapeutic, Embolization
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.
Interventions
DEVICEThe EMBA Peripheral Embolization Device
arterial and venous embolization in the peripheral vasculature
Sponsors
EMBA Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel occlusion (assessed by CTA) | 30 Days | vessel occlusion as assessed by CTA |
Countries
New Zealand
Outcome results
None listed