The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.
The purpose of the study is to compare efficacy data on subjects randomized to treatment with percutaneous transluminal angioplasty (PTA) and the FLAIR™ Endovascular Stent Graft versus subjects randomized to treatment with PTA only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft
Treatment of stenoses with PTA only
Access Connections
Bamberg, South Carolina, United States
ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.
To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure.
Time frame: 12 months
The Index of Patency Function (IPF) [the Average Number of Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure.
The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the arteriovenous (AV) access circuit in order to maintain vascular access for hemodialysis.
Time frame: 12 months
The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.
Time frame: 12 months
To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure
The estimated number of re-interventions to the access circuit until graft abandonment or through 12 months post-index procedure was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.
Time frame: Patient Follow-Up
Post-Intervention Assisted Primary Patency at 12 Months
Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.
Time frame: 12 months
Post-intervention Secondary Patency (PSP) at 12 Months
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Postintervention secondary patency \[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.
Time frame: 12 months
Procedural Success
Procedural success was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. Procedural success is defined as anatomic success and at least one indicator of hemodynamic or clinical success.
Time frame: Patient Follow-Up
Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure
The incidence of device-related and procedure-related serious adverse events (SAEs) from the index procedure through 30 days post procedure is summarized. The purpose of this analysis was to assess the effectiveness of the Bard Peripheral Vascular (BPV) clinician training program.
Time frame: Patient Follow-Up
Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months
Serious Adverse Events at 12 months are reported for all 270 subjects.
Time frame: 12 months
Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention.
Access Circuit Primary Patency (ACPP) was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months.
Time frame: 24 months
To Estimate Safety at 24 Months.
To estimate the percentage of participants without safety issues through 24 months.
Time frame: 24 months
Post-Intervention Assisted Primary Patency at 24 Months
Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.
Time frame: 24 month follow up
Post-intervention Secondary Patency at 24 Months
Postintervention secondary patency \[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.
Time frame: 24 months
Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months.
The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.
Time frame: 24 months
Post-Intervention Assisted Primary Patency at 6 Months
Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.
Time frame: 6 month follow up
Post-intervention Secondary Patency at 6 Months
Postintervention secondary patency \[PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial\] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.
Time frame: 6 month follow-up