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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)
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Scientific title
Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients
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Secondary ID [1]
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VAP-0001
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Universal Trial Number (UTN)
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Trial acronym
NEAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Efficacy Endpoint:
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Assessment method [1]
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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.
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Timepoint [1]
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within 3 months
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Secondary outcome [1]
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Safety Endpoint
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Assessment method [1]
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The percentage of patients who experience one or more serious study device related adverse events during the first 3 months following AVF creation
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Timepoint [1]
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within 3 months
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Secondary outcome [2]
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EndoAVF-related Re-intervention Rate
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Assessment method [2]
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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.
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Timepoint [2]
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3, 6 and 12 months
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Secondary outcome [3]
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Primary Patency
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Assessment method [3]
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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.
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Timepoint [3]
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3, 6 and 12 months
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Secondary outcome [4]
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Cumulative Patency
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Assessment method [4]
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Time from creation to the abandonment of endoAVF (censor patients with renal transplant)
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Timepoint [4]
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3, 6 and 12 months
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Secondary outcome [5]
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Functional Usability
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Assessment method [5]
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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.
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Timepoint [5]
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4 weeks post procedure, up to 12 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2016
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Sample size
Target
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [2]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
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3181 - Melbourne
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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Country [2]
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Canada
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State/province [2]
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Nova Scotia
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Canada
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State/province [4]
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Quebec
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Country [5]
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New Zealand
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State/province [5]
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Grafton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
TVA Medical Inc.
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02036671
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Charmaine Lok, MD, MSC, FRCPC
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Address
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The Toronto General Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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
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