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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02036671




Registration number
NCT02036671
Ethics application status
Date submitted
10/01/2014
Date registered
15/01/2014
Date last updated
27/07/2018

Titles & IDs
Public title
Novel Endovascular Access Trial (NEAT)
Scientific title
Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients
Secondary ID [1] 0 0
VAP-0001
Universal Trial Number (UTN)
Trial acronym
NEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: EndoAVF - The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy Endpoint:
Timepoint [1] 0 0
within 3 months
Secondary outcome [1] 0 0
Safety Endpoint
Timepoint [1] 0 0
within 3 months
Secondary outcome [2] 0 0
EndoAVF-related Re-intervention Rate
Timepoint [2] 0 0
3, 6 and 12 months
Secondary outcome [3] 0 0
Primary Patency
Timepoint [3] 0 0
3, 6 and 12 months
Secondary outcome [4] 0 0
Cumulative Patency
Timepoint [4] 0 0
3, 6 and 12 months
Secondary outcome [5] 0 0
Functional Usability
Timepoint [5] 0 0
4 weeks post procedure, up to 12 months

Eligibility
Key inclusion criteria
* Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
* Adult (age >18 years old).
* Established, non-reversible kidney failure requiring hemodialysis.
* Written informed consent obtained.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Functioning surgical access in the planned treatment arm.
* Pregnant women.
* New York Heart Association (NYHA) class III or IV heart failure.
* Allergy to contrast dye.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Nova Scotia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
New Zealand
State/province [5] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TVA Medical Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Charmaine Lok, MD, MSC, FRCPC
Address 0 0
The Toronto General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02036671