Clinical trial NCT02099344: Artegraft Versus Propaten Dialysis Grafts
Official title: A Prospective, Randomized Study of the Artegraft vs Propaten Vascular Grafts for Renal Failure Patients Requiring Dialysis Access
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: ESRD
Renal Failure
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized to either

Combination product- device/biologic Artegraft® or Gore® Propaten®.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft
timeFrame: 12 months
Secondary outcomes:
measure: Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft
timeFrame: 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Earl Schuman, MD
role: PRINCIPAL_INVESTIGATOR
References: