1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002).
2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).

1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002).
2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).

1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002).
2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).

Use of duplex ultrasonography to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.

Use of duplex ultrasonography to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.

Use of duplex ultrasonography to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.

Duplex ultrasound was used to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.

No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.

No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.

Adjudicated using the standard definition of access-related infections (CDC; 2013).

Using Dialysis Event Surveillance Manual: CDC; 2013.

Rate of intervention defined as the number of interventions per participant per year while conduit is patent (i.e., has not been abandoned).

Number of successful interventions to achieve/maintain Secondary Patency.

Total number of interventions performed by treatment group stratified by any use of balloon size no > 6 millimeters.

Non-oversized ballon use (no greater than 6 mm)

Total number of interventions performed by treatment group stratified by any use of balloon size greater than 6 millimeters.

Oversized ballon use (greater than 6 mm)

Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access

Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access

Dialysis efficiency as assessed by spKt/Vurea (obtained from dialysis unit for a subset of subjects) will be summarized descriptively. The most recent available data prior to the study visits will be used for the analysis.

Twenty sites provided at least 1 spKt/Vurea measurement. spKt/Vurea: measure of dialysis adequacy for a single hemodialysis treatment using the single pooled method.

Female and Male

Severity Assessment Standard

1. Mild: Events require minimal or no treatment and do not interfere with the subject's daily activities.
2. Moderate: Events result in a low level of inconvenience or concern with the therapeutic measures. May cause some interference with functioning.
3. Severe: Events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating.
4. Life-threatening: Any adverse event that places the subject or participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death.
5. Death: Death related to Adverse Event.

Collection of all Adverse Events beginning on Day 0 after implantation up to 2 years post implantation (Month 24).

Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline

Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline

Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms.

Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms.

Assessed by ultrasound

Assessed by ultrasound

Assessed by ultrasound

Assessed by ultrasound

Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline

Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline

Duplex ultrasonography: diameter of the mid-conduit lumen

Duplex ultrasonography: diameter of the mid-conduit lumen

Duplex ultrasonography: diameter of the mid-conduit lumen