Chronic Kidney Disease (CKD)
Conditions
Keywords
Chronic kidney disease, Arteriovenous fistula, Hemodialysis, Vascular access
Brief summary
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.
Interventions
DEVICEEndovasccular AVF (EndoAVF)
The FLEX System will be used to endovascularly 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 80 Years
Healthy volunteers
No
Inclusion criteria
* Eligible for a native surgical arteriovenous fistula, as determined by the treating physician. * Adult (age \>18 years old). * Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis. * Written informed consent obtained
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 6 months | The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access Functionality | 6 months | The functionality of the AVF will be measured based on use of the AVF with two needles for at least 75% of dialysis sessions over a 4-week period following at least a one month maturation period. |
Countries
Paraguay
Outcome results
None listed