AV Fistula, End Stage Renal Disease, Kidney Failure
Conditions
Keywords
End Stage Renal Disease, Hemodialysis, AV fistula, Kidney failure
Brief summary
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.
Interventions
DEVICEVenous Window Needle Guide
Subcutaneous, extravascular needle guide made of medical-grade titanium
Sponsors
Vital Access Corp.
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
* Deep, uncannulatable, upper extremity arteriovenous fistula * Minimum arteriovenous fistula flow 400 ml/min * One year life expectancy
Exclusion criteria
* Non-transposed basilic or brachial vein arteriovenous fistula * History of peripheral vascular disease * History of cardiovascular disease * History of cerebral vascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis | 3 months | Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide | 6 months | Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Venous Window Needle Guide Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Venous Window Needle Guide |
|---|---|
| Age, Continuous | 60 Years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 54 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 54 |
| serious Total, serious adverse events | 8 / 54 |
Outcome results
Primary
Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis
Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venous Window Needle Guide | Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis | 49 participants |
Secondary
Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide
Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venous Window Needle Guide | Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide | 14 participants |