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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Treatment: Devices - The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access

Experimental: EndoAVF - The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access


Treatment: Devices: The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access


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

Outcomes
Primary outcome [1] 0 0
Primary Efficacy Endpoint: - The percentage of patients with fistula maturation/usability defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR patient was dialyzed using 2 needles.
Timepoint [1] 0 0
within 3 months
Secondary outcome [1] 0 0
Safety Endpoint - The percentage of patients who experience one or more serious study device related adverse events during the first 3 months following AVF creation
Timepoint [1] 0 0
within 3 months
Secondary outcome [2] 0 0
EndoAVF-related Re-intervention Rate - The re-intervention rate for endoAVF (defined as any intervention required to maintain or re-establish patency) will be calculated at 3, 6 and 12 months post index procedure.
Timepoint [2] 0 0
3, 6 and 12 months
Secondary outcome [3] 0 0
Primary Patency - Time from successful endoAVF creation to the first intervention designed to address thrombosis or stenosis, assist in maturation or cannulation of endoAVF, or endoAVF abandonment.
Timepoint [3] 0 0
3, 6 and 12 months
Secondary outcome [4] 0 0
Cumulative Patency - Time from creation to the abandonment of endoAVF (censor patients with renal transplant)
Timepoint [4] 0 0
3, 6 and 12 months
Secondary outcome [5] 0 0
Functional Usability - 2-needle cannulation of the endoAVF for prescribed dialysis in = 2/3 of dialysis sessions over a 4 consecutive week period within 12 months of endoAVF creation.
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
Gender
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
N/A
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
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)
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
The objective of this study is to evaluate the safety and efficacy of the FLEX System when
used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with
Chronic Kidney Disease (CKD) who require hemodialysis vascular access.
Trial website
https://clinicaltrials.gov/show/NCT02036671
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

Summary results
Other publications