Chronic Kidney DiseaseNEATNCT02036671
Novel Endovascular Access Trial (NEAT)
A study testing The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access in people with Chronic Kidney Disease, run by C. R. Bard at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Jan 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Canada6 sites
QE II Health Sciences Center
Halifax, Nova Scotia, B3H 2Y9
London Health Sciences Centre
London, Ontario, N6A 5W9
CHUM, Notre-Dame Hospital
Montreal, Quebec, H2L 4M1
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
The Toronto General Hospital
Toronto, Ontario, M5G 2C4
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Australia2 sites
Alfred Hospital
Melbourne, Victoria, 3181
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
Official title: Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients
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.
Read the detailed description
This is a 12 month multi-center non-randomized investigational study to evaluate the safety and efficacy of the FLEX system to create an endovascular AVF in patients with CKD who require hemodialysis vascular access.
- Conditions
- Chronic Kidney Disease
- Being tested
- The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
- Keywords
- Arteriovenous fistula, Fistula, Chronic kidney disease, Percutaneous, Kidney Disease, Kidney Failure, Chronic, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, CKD, hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Arteriovenous Fistula, Fistula, Kidney Diseases, Kidney Failure, Chronic, Urologic Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular accessDevice
| Study group | Role | What they receive |
|---|---|---|
| EndoAVF | Experimental | The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access Receives: Device: The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 3 months
Secondary outcomes (5)
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
Measured: within 3 months
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.
Measured: 3, 6 and 12 months
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.
Measured: 3, 6 and 12 months
Cumulative Patency
Time from creation to the abandonment of endoAVF (censor patients with renal transplant)
Measured: 3, 6 and 12 months
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.
Measured: 4 weeks post procedure, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charmaine Lok, MD, MSC, FRCPC, Principal investigator, The Toronto General HospitalDheeraj Rajan, MD, BSc, FRCPC, FSIR, Principal investigator, The Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036671
- Sponsor's protocol ID
- VAP-0001
- Acronym
- NEAT
- Status last verified
- Nov 2025
- First submitted
- 10 Jan 2014
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02036671
- Acronym / sponsor ID
- NEAT / VAP-0001
- Conditions
- Chronic Kidney Disease
- Keywords
- Arteriovenous fistula, Fistula, Chronic kidney disease, Percutaneous, Kidney Disease, Kidney Failure, Chronic, Urologic Diseases, Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 12 month multi-center non-randomized investigational study to evaluate the safety and efficacy of the FLEX system to create an endovascular AVF in patients with CKD who require hemodialysis vascular access.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoAVF | Experimental | Device: The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular accessThe FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access | Device | EndoAVF |
Primary outcome
Primary Efficacy Endpoint:
Time frame: within 3 months
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.
5 secondary outcomes
Safety Endpoint
Time frame: within 3 months
EndoAVF-related Re-intervention Rate
Time frame: 3, 6 and 12 months
Primary Patency
Time frame: 3, 6 and 12 months
Cumulative Patency
Time frame: 3, 6 and 12 months
Functional Usability
Time frame: 4 weeks post procedure, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charmaine Lok, MD, MSC, FRCPC principal investigator
The Toronto General Hospital
Dheeraj Rajan, MD, BSc, FRCPC, FSIR principal investigator
The Toronto General Hospital
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access in people with Chronic Kidney Disease, run by C. R. Bard at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: (time frame: within 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.