Propaten Randomized Investigation on Cost-benefit and Efficacy

Study Design: This is a prospective, multi-institution, parallel-group, single-blinded,
randomized-controlled, two-arm, effectiveness study comparing heparin-bonded (Propaten®)
versus non-heparin-bonded arteriovenous grafts.

Procedure: In patients without usable native vein, prosthetic arteriovenous grafts will be
implanted for hemodialysis access. Patients will be randomized intraoperatively to either
conventional (Gore® Stretch) or heparin-bonded grafts (Gore® Propaten).

Course of Study: The study will accrue patients over the course of 5 years.

Enrollment: Enrollment will consist of adult patients who require hemodialysis. If the
patient cannot have a native vein arteriovenous fistula, the patient is a candidate for
arteriovenous graft. Patients will be screened and consented preoperatively. If the
intraoperative decision is made that the patient will require a graft, randomization will
occur and the patient will be considered enrolled.

Recruitment: The target population comprises of all adult patients aged 18 years and above
with end stage renal disease requiring arteriovenous access for hemodialysis. The target for
enrollment will be 200 patients.

Risks: The standard or known adverse events associated with graft implantation include
thrombosis, infection, pseudoaneurysm, hematoma, and venous stenosis. There are case reports
of heparin sensitivity. The investigators do not expect any additional physical risks other
than an unintentional disclosure of sensitive patient health information.

Data Safety Monitoring: As the Principal Investigator of this study, Dr. Charlton-Ouw from
the Department of Cardiothoracic and Vascular Surgery at The University of Texas at Houston
Medical School will conduct the data safety monitoring of this study. He will annually meet
with all other co-investigators to review the patients enrolled in this study. As part of the
data safety monitoring plan, all patients enrolled until that point in time would be
unblinded in order to review the outcomes. Interim analyses will be conducted at the one-year
follow up time.

IND#: The devices that will be used are already approved by the FDA and do not have IND#.

Proposed Funding Source: The study is internally funded.

Communication of Study Results: The communication of study results will occur only between
authorized individuals who are listed to take part in the study through our department. The
individuals who will take part in the study will acknowledge and adhere to the importance of
patient safety and the protection of their private information. The results of this study
will be analyzed and published after the approval of the principal investigator,
co-investigators, and biostatistician in a peer-reviewed scientific journal and/or presented
at an international/national scientific conference or meeting regardless of outcome.

Inclusion Criteria:

- Aged ≥18 years of all ethnicities

- End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR <15ml/min
1.73m2) per National Kidney Foundation guidelines

- Currently undergoing hemodialysis with a failure of previous access

- Expected to undergo hemodialysis within 6 months of presentation

Exclusion Criteria:

- Unable/refuse to abide with follow-up

- Known hypercoagulability syndrome or a bleeding disorder

- On a previous anticoagulant treatment

- Intraoperative decision in favor of fistula instead of graft

- Pregnant or breast-feeding women

- A documented history of heparin induced thrombocytopenia or allergy

- Active infections

- Evidence or suspicion of central vein stenosis