Chronic Kidney Disease
Conditions
Keywords
Arteriovenous fistula, Fistula, Chronic kidney disease, Percutaneous, Kidney Disease, Kidney Failure, Chronic, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, CKD, hemodialysis
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.
Interventions
DEVICEThe FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Cumulative Patency | 3, 6 and 12 months | Time from creation to the abandonment of endoAVF (censor patients with renal transplant) |
| 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. |
Countries
Australia, Canada, New Zealand
Outcome results
None listed