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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Alfred Hospital
Melbourne, Victoria, Australia
St. Paul's Hospital
Vancouver, British Columbia, Canada
QE II Health Sciences Center
Halifax, Nova Scotia, Canada
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.
Time frame: within 3 months
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
Time frame: 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.
Time frame: 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.
Time frame: 3, 6 and 12 months
Cumulative Patency
Time from creation to the abandonment of endoAVF (censor patients with renal transplant)
Time frame: 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.
Time frame: 4 weeks post procedure, up to 12 months
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