Artegraft Versus Propaten Dialysis Grafts

Phase 4TerminatedNCT02099344

Kaiser Permanente1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ESRD Renal Failure

Interventions

ArtegraftDEVICE

Surgical placement of graft for hemodialysis access

PropatenDEVICE

Surgical placement of graft for hemodialysis access

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kaiser Permanente Northwest

Portland, Oregon, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.