Novel Endovascular Access Trial (NEAT)

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Device: The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access

• Registration Number: NCT02036671
• Lead Sponsor: TVA Medical Inc.

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Primary Completion: 2015-12
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2018-07-25
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint:	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.

Secondary Outcome Measures

Name	Time	Method
Safety Endpoint	within 3 months	The percentage of patients who experience one or more serious study device related adverse events during the first 3 months following AVF creation
Cumulative Patency	3, 6 and 12 months	Time from creation to the abandonment of endoAVF (censor patients with renal transplant)
EndoAVF-related Re-intervention Rate	3, 6 and 12 months	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	3, 6 and 12 months	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.
Functional Usability	4 weeks post procedure, up to 12 months	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.

Trial Locations

Locations (9)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

QE II Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada

CHUM, Notre-Dame Hospital; 🇨🇦 Montreal, Quebec, Canada

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Lakeridge Health Oshawa; 🇨🇦 Oshawa, Ontario, Canada

The Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Auckland City Hospital; 🇳🇿 Grafton, New Zealand