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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02335788




Registration number
NCT02335788
Ethics application status
Date submitted
6/01/2015
Date registered
12/01/2015
Date last updated
10/02/2015

Titles & IDs
Public title
EMBA Peripheral Embolization Device ("EPED") Study
Scientific title
EMBA Peripheral Embolization Device ("EPED") Study
Secondary ID [1] 0 0
PRT-EPE-0028
Universal Trial Number (UTN)
Trial acronym
EPED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Embolization 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - The EMBA Peripheral Embolization Device

Other: Single arm - EMBA PED - The EMBA Peripheral Embolization Device when indicated for arterial and venous embolization in the peripheral vasculature.


Treatment: Devices: The EMBA Peripheral Embolization Device
arterial and venous embolization in the peripheral vasculature

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target vessel occlusion (assessed by CTA) - vessel occlusion as assessed by CTA
Timepoint [1] 0 0
30 Days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMBA Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT02335788
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MD
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrew Holden, MD
Address 0 0
Country 0 0
Phone 0 0
+011 64 (09) 307-4949
Fax 0 0
Email 0 0
AndrewH@adhb.govt.nz
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02335788