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Novel Endovascular Access Trial (NEAT) (NEAT)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
Sponsored by
TVA Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Arteriovenous fistula, Fistula, Chronic kidney disease, Percutaneous, Kidney Disease, Kidney Failure, Chronic, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, CKD, hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Princess Alexandra Hospital
  • Alfred Hospital
  • St. Paul's Hospital
  • QE II Health Sciences Center
  • London Health Sciences Centre
  • Lakeridge Health Oshawa
  • The Toronto General Hospital
  • CHUM, Notre-Dame Hospital
  • Auckland City Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EndoAVF

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
Cumulative Patency
Time from creation to the abandonment of endoAVF (censor patients with renal transplant)
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.

Full Information

First Posted
January 10, 2014
Last Updated
July 25, 2018
Sponsor
TVA Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02036671
Brief Title
Novel Endovascular Access Trial (NEAT)
Acronym
NEAT
Official Title
Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TVA Medical Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Arteriovenous fistula, Fistula, Chronic kidney disease, Percutaneous, Kidney Disease, Kidney Failure, Chronic, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, CKD, hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EndoAVF
Arm Type
Experimental
Arm Description
The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
Intervention Type
Device
Intervention Name(s)
The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint:
Description
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.
Time Frame
within 3 months
Secondary Outcome Measure Information:
Title
Safety Endpoint
Description
The percentage of patients who experience one or more serious study device related adverse events during the first 3 months following AVF creation
Time Frame
within 3 months
Title
EndoAVF-related Re-intervention Rate
Description
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.
Time Frame
3, 6 and 12 months
Title
Primary Patency
Description
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.
Time Frame
3, 6 and 12 months
Title
Cumulative Patency
Description
Time from creation to the abandonment of endoAVF (censor patients with renal transplant)
Time Frame
3, 6 and 12 months
Title
Functional Usability
Description
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.
Time Frame
4 weeks post procedure, up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charmaine Lok, MD, MSC, FRCPC
Organizational Affiliation
The Toronto General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dheeraj Rajan, MD, BSc, FRCPC, FSIR
Organizational Affiliation
The Toronto General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
QE II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
The Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
CHUM, Notre-Dame Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Auckland City Hospital
City
Grafton
ZIP/Postal Code
1142
Country
New Zealand

12. IPD Sharing Statement

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Novel Endovascular Access Trial (NEAT)

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