Overview

This trial has been completed.

Condition chronic kidney disease
Treatment the flex system will be used to percutaneously create a fistula in ckd patients who require hemodialysis vascular access
Sponsor TVA Medical Inc.
Start date January 2014
End date December 2015
Trial size 80 participants
Trial identifier NCT02036671, VAP-0001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Outcomes

Measure
Primary Efficacy Endpoint:
time frame: within 3 months

Secondary Outcomes

Measure
Safety Endpoint
time frame: within 3 months
EndoAVF-related Re-intervention Rate
time frame: 3, 6 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients
Principal investigator Charmaine Lok, MD, MSC, FRCPC
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by TVA Medical Inc..