Novel Endovascular Access Trial (NEAT)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Kidney Disease

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EndoAVF<br>The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access | Device: The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Cumulative Patency | Time from creation to the abandonment of endoAVF (censor patients with renal transplant) | 3, 6 and 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, Arteriovenous fistula, Fistula, Chronic kidney disease, Percutaneous, Kidney Disease, Kidney Failure, Chronic, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, hemodialysis