Hemodialysis, Renal Failure
Conditions
Keywords
Hemodialysis, Stent Graft, Venous Anastomosis, Arteriovenous Grafts
Brief summary
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.
Detailed description
The primary effectiveness hypothesis is to demonstrate that the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface will extend the period of target lesion primary patency as compared to PTA. The primary safety hypothesis is to demonstrate that the proportion of subjects remaining free from major device, procedure, and treatment site-related adverse events through 30 days post-procedure in the GORE® VIABAHN® Device group is not inferior to that of the PTA group.
Interventions
DEVICEGORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Deployment of investigational stent graft at the venous anastomosis
Percutaneous Transluminal Angioplasty at the venous anastomosis
Sponsors
W.L.Gore & Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hemodialysis patient with a dysfunctional or thrombosed forearm or upper arm prosthetic vascular access graft. * The target lesion starts less than or equal to 30 mm from the venous anastomosis. * The target lesion has \> 50% stenosis as measured per protocol. * The patient has a maximum of one secondary stenosis.
Exclusion criteria
* The age of the hemodialysis access graft is less than or equal to 30 days old from the date of the study procedure. * The patient has undergone an intervention (surgical or percutaneous) of the vascular access circuit less than or equal to 30 days from the date of the study procedure. * The secondary lesion is an occlusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Primary Patency at 6 Months | 6 months | Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve. |
| Target Lesion Primary Patency at 12 Months | 12 Months | Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve. |
| Target Lesion Primary Patency at 24 Months | 24 Months | Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. P-Value calculated from 24-month data cohort after study completion. |
| Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure | 30 days | The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access Secondary Patency [12 Months] Units Percentage of Subjects | 12 months | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. |
| Access Secondary Patency [24 Months] Units Percentage of Subjects | 24 months | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. 24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. |
| Circuit Primary Patency | 6 months | Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit. P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve. |
| Circuit Primary Patency [12 Months] Units Percentage of Subjects | 12months | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. |
| Assisted Primary Patency at 6 Months | 6 months | Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Six-month estimate of assisted primary patency derived from Kaplan-Meier curve. |
| Clinical Success | Following Index Procedure | The resumption of normal dialysis for at least one session following study treatment (Index Procedure). |
| Anatomic Success | Index Procedure | Less than 30 percent residual stenosis following study treatment (Index Procedure). |
| Procedural Success | Following Index Procedure | Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success. |
| Circuit Primary Patency [24 Months] Units Percentage of Subjects | 24 months | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. |
| Assisted Primary Patency at 12 Months | 12 months | Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve. |
| Assisted Primary Patency at 24 Months | 24 months | Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve. |
| Access Secondary Patency at 6 Months | 6 months | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Six-month estimate of secondary access patency derived from Kaplan-Meier curve. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VIABAHN Treatment Group Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm.
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis. | 145 |
| PTA Treatment Group Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm.
Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis. | 148 |
| Total | 293 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 23 | 22 |
| Overall Study | Graft Abandonment | 48 | 56 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Miscellaneous | 7 | 1 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | VIABAHN Treatment Group | PTA Treatment Group | Total |
|---|---|---|---|
| Age, Continuous | 62.2 Years STANDARD_DEVIATION 12.9 | 61.3 Years STANDARD_DEVIATION 15 | 61.7 Years STANDARD_DEVIATION 14 |
| Age of Vascular Access Graft | 1.93 Years STANDARD_DEVIATION 1.92 | 2.28 Years STANDARD_DEVIATION 2.64 | 2.11 Years STANDARD_DEVIATION 2.31 |
| Body Mass Index | 29.7 Kg/m^2 STANDARD_DEVIATION 9.1 | 29.5 Kg/m^2 STANDARD_DEVIATION 8.6 | 29.6 Kg/m^2 STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 30 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 126 Participants | 114 Participants | 240 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| History of Diabetes History of Diabetes = NO | 51 Participants | 50 Participants | 101 Participants |
| History of Diabetes History of Diabetes = YES | 94 Participants 64.8 | 98 Participants 66.2 | 192 Participants |
| History of Hypertension History of Hypertension = NO | 2 Participants | 4 Participants | 6 Participants |
| History of Hypertension History of Hypertension = YES | 143 Participants | 144 Participants | 287 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 74 Participants | 80 Participants | 154 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 61 Participants | 56 Participants | 117 Participants |
| Region of Enrollment United States | 145 Participants | 148 Participants | 293 Participants |
| Sex: Female, Male Female | 76 Participants | 75 Participants | 151 Participants |
| Sex: Female, Male Male | 69 Participants | 73 Participants | 142 Participants |
| Total Number of Prior Interventions at the Target Lesions | 1.85 Number of Prior Interventions STANDARD_DEVIATION 2.2 | 1.81 Number of Prior Interventions STANDARD_DEVIATION 2.34 | 1.83 Number of Prior Interventions STANDARD_DEVIATION 2.27 |
| Total Number of Prior Interventions to the Current Prosthetic Graft or Circuit | 2.28 Number of Prior Interventions STANDARD_DEVIATION 2.75 | 2.26 Number of Prior Interventions STANDARD_DEVIATION 2.9 | 2.27 Number of Prior Interventions STANDARD_DEVIATION 2.82 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 145 | 8 / 148 |
| serious Total, serious adverse events | 78 / 145 | 77 / 148 |
Outcome results
Primary
Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure
The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure | 0 Participants |
| PTA Treatment Group | Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure | 2 Participants |
p-value: <0.001Z-test
Primary
Target Lesion Primary Patency at 12 Months
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve.
Time frame: 12 Months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Target Lesion Primary Patency at 12 Months | 30.2 Percentage of Subjects |
| PTA Treatment Group | Target Lesion Primary Patency at 12 Months | 18.2 Percentage of Subjects |
Primary
Target Lesion Primary Patency at 24 Months
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. P-Value calculated from 24-month data cohort after study completion.
Time frame: 24 Months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Target Lesion Primary Patency at 24 Months | 15.7 Percentage of Subjects |
| PTA Treatment Group | Target Lesion Primary Patency at 24 Months | 9.9 Percentage of Subjects |
p-value: 0.008Log Rank
Primary
Target Lesion Primary Patency at 6 Months
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve.
Time frame: 6 months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Target Lesion Primary Patency at 6 Months | 52.9 Percentage of Subjects |
| PTA Treatment Group | Target Lesion Primary Patency at 6 Months | 35.5 Percentage of Subjects |
Secondary
Access Secondary Patency [12 Months] Units Percentage of Subjects
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
Time frame: 12 months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Access Secondary Patency [12 Months] Units Percentage of Subjects | 82.7 Percentage of Subjects |
| PTA Treatment Group | Access Secondary Patency [12 Months] Units Percentage of Subjects | 78.6 Percentage of Subjects |
Secondary
Access Secondary Patency [24 Months] Units Percentage of Subjects
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. 24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
Time frame: 24 months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Access Secondary Patency [24 Months] Units Percentage of Subjects | 68.9 Percentage of Subjects |
| PTA Treatment Group | Access Secondary Patency [24 Months] Units Percentage of Subjects | 66.6 Percentage of Subjects |
Secondary
Access Secondary Patency at 6 Months
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Six-month estimate of secondary access patency derived from Kaplan-Meier curve.
Time frame: 6 months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Access Secondary Patency at 6 Months | 91.2 Percentage of Subjects |
| PTA Treatment Group | Access Secondary Patency at 6 Months | 86.5 Percentage of Subjects |
p-value: 0.475Log Rank
Secondary
Anatomic Success
Less than 30 percent residual stenosis following study treatment (Index Procedure).
Time frame: Index Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VIABAHN Treatment Group | Anatomic Success | Anatomic Success = NO | 0 Participants |
| VIABAHN Treatment Group | Anatomic Success | Anatomic Success = YES | 131 Participants |
| PTA Treatment Group | Anatomic Success | Anatomic Success = YES | 116 Participants |
| PTA Treatment Group | Anatomic Success | Anatomic Success = NO | 22 Participants |
p-value: <0.001Fisher Exact
Secondary
Assisted Primary Patency at 12 Months
Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve.
Time frame: 12 months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Assisted Primary Patency at 12 Months | 43.5 Percentage of Subjects |
| PTA Treatment Group | Assisted Primary Patency at 12 Months | 35.3 Percentage of Subjects |
Secondary
Assisted Primary Patency at 24 Months
Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve.
Time frame: 24 months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Assisted Primary Patency at 24 Months | 29.2 Percentage of Subjects |
| PTA Treatment Group | Assisted Primary Patency at 24 Months | 29.0 Percentage of Subjects |
Secondary
Assisted Primary Patency at 6 Months
Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Six-month estimate of assisted primary patency derived from Kaplan-Meier curve.
Time frame: 6 months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Assisted Primary Patency at 6 Months | 56.2 Percentage of Subjects |
| PTA Treatment Group | Assisted Primary Patency at 6 Months | 51.1 Percentage of Subjects |
p-value: 0.53Log Rank
Secondary
Circuit Primary Patency
Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit. P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Circuit Primary Patency | 43.4 Percentage of Subjects |
| PTA Treatment Group | Circuit Primary Patency | 29.4 Percentage of Subjects |
p-value: 0.035Log Rank
Secondary
Circuit Primary Patency [12 Months] Units Percentage of Subjects
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
Time frame: 12months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Circuit Primary Patency [12 Months] Units Percentage of Subjects | 21.4 Percentage of Subjects |
| PTA Treatment Group | Circuit Primary Patency [12 Months] Units Percentage of Subjects | 15.2 Percentage of Subjects |
Secondary
Circuit Primary Patency [24 Months] Units Percentage of Subjects
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
Time frame: 24 months
Population: Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIABAHN Treatment Group | Circuit Primary Patency [24 Months] Units Percentage of Subjects | 9.6 Percentage of Subjects |
| PTA Treatment Group | Circuit Primary Patency [24 Months] Units Percentage of Subjects | 6.8 Percentage of Subjects |
Secondary
Clinical Success
The resumption of normal dialysis for at least one session following study treatment (Index Procedure).
Time frame: Following Index Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VIABAHN Treatment Group | Clinical Success | Clinical Success = YES | 128 Participants |
| VIABAHN Treatment Group | Clinical Success | Clinical Success = NO | 3 Participants |
| PTA Treatment Group | Clinical Success | Clinical Success = YES | 135 Participants |
| PTA Treatment Group | Clinical Success | Clinical Success = NO | 3 Participants |
p-value: 1Fisher Exact
Secondary
Procedural Success
Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.
Time frame: Following Index Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VIABAHN Treatment Group | Procedural Success | Procedural Success = YES | 128 Participants |
| VIABAHN Treatment Group | Procedural Success | Procedural Success = NO | 3 Participants |
| PTA Treatment Group | Procedural Success | Procedural Success = YES | 113 Participants |
| PTA Treatment Group | Procedural Success | Procedural Success = NO | 25 Participants |
p-value: <0.001Fisher Exact