ESRD, Renal Failure
Conditions
Brief summary
Compare Artegraft and Propaten grafts for use in dialysis access to see if one performs better than the other. How long each one lasts until a complication arises or until the graft is no longer used will be compared. The study hypothesis is that the Artegraft, being an actual blood vessel, will work better than the manufactured Propaten graft.
Detailed description
Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care. Patients will be assessed at 2-3 weeks post-operatively and again at 6 and 12 months for flow characteristics, dialysis adequacy and graft associated complications such as stenosis, infection and thrombosis. Data on urea reduction ratio (URR), kinetic modeling (Kt/V), and access flow (QB) will be collected at 3, 6, 9 and 12 months via phone call to the hemodialysis center in order to evaluate patency and function. Access complications (stenosis, thrombosis, infection) will be treated per our standard protocol. These data will be recorded and then primary, assisted primary and secondary patency rates will be calculated and the graft arms compared using life table analysis.
Interventions
DEVICEArtegraft
Surgical placement of graft for hemodialysis access
DEVICEPropaten
Surgical placement of graft for hemodialysis access
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized to either Combination product- device/biologic Artegraft® or Gore® Propaten®.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years of age * Candidate for hemodialysis * Not a candidate for native AV fistula * In need of a new AV graft in the upper arm location * Artery and vein \> 3mm. * Medically stable and have a life expectancy of ≥ 12 months * The patient or legal guardian understands the study and is willing to comply with the requirements.
Exclusion criteria
* \< 18 years of age * Current history or within 6 months of IV drug abuse * Chronic hypotension (\<100 mm systolic pressure) not responsive to treatment * Pregnant or lactating * Known hypercoagulable state * Requires only a revision of an existing graft * Receiving artery or vein is less than 3 mm in diameter at the time of implantation * Known axillary/subclavian occlusion or stenosis that has not been treated * Known or suspected systemic infection * Heparin sensitivity (known HIT) * Enrolled in another investigational study. * Subject has more than 1 graft in target limb.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft | 12 months | The primary outcome will be determined by Kaplan-Meier life table analysis. Patency determination will be from access creation until the first occlusion of the graft. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft | 12 months | Complication incidence will be collected from the time of access creation until the graft fails and is abandoned. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Propaten Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access | 1 |
| Artegraft Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Propaten |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Age, Continuous | 56 years | 56 years |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft
The primary outcome will be determined by Kaplan-Meier life table analysis. Patency determination will be from access creation until the first occlusion of the graft.
Time frame: 12 months
Population: Data not collected due to early study termination
Secondary
Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft
Complication incidence will be collected from the time of access creation until the graft fails and is abandoned.
Time frame: 12 months
Population: Data not collected due to early study termination