Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Disease
- Sponsor
- C. R. Bard
- Enrollment
- 80
- Locations
- 9
- Primary Endpoint
- Primary Efficacy Endpoint:
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Safety Endpoint(within 3 months)
- Cumulative Patency(3, 6 and 12 months)
- EndoAVF-related Re-intervention Rate(3, 6 and 12 months)
- Primary Patency(3, 6 and 12 months)
- Functional Usability(4 weeks post procedure, up to 12 months)