Novel Endovascular Access Trial (NEAT)

Chronic Kidney Disease Clinical Trial

— NEAT  

Official title:

Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036671
• Other study ID #: VAP-0001
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: TVA Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Canada	QE II Health Sciences Center	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	CHUM, Notre-Dame Hospital	Montreal	Quebec
Canada	Lakeridge Health Oshawa	Oshawa	Ontario
Canada	The Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
New Zealand	Auckland City Hospital	Grafton

Sponsors (1)

Lead Sponsor	Collaborator
TVA Medical Inc.

Countries where clinical trial is conducted

Australia,  Canada,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 3 months
Secondary	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	within 3 months
Secondary	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.	3, 6 and 12 months
Secondary	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.	3, 6 and 12 months
Secondary	Cumulative Patency	Time from creation to the abandonment of endoAVF (censor patients with renal transplant)	3, 6 and 12 months
Secondary	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.	4 weeks post procedure, up to 12 months