End Stage Renal Disease
Conditions
Keywords
Hemodialysis, Vascular Graft
Brief summary
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other arteriovenous grafts (AVGs). \> \>\> \> \>\> A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion. \> \>\> \> \>\> Subjects will be selected from up to 20 Investigational Sites.
Interventions
Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\> 1. Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. \> \>\> 2. Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. \> \>\> 3. The patient must be able to have the vascular access graft placed in an upper extremity. \> \>\> 4. The patient is 18 years of age or older. \> \>\> 5. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. \> \>\> 6. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. \> \>\> 7. The patient or his/her legal guardian is willing to provide informed consent. \> \>\> \> \>\> \> \>\>
Exclusion criteria
\> \>\> <!-- --> 1. The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.\> \>\> 2. The patient currently has a known or suspected systemic infection.\> \>\> 3. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\> \>\> 4. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. \> \>\> 5. The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.\> \>\> 6. The patient is enrolled in another investigational study.\> \>\> 7. The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\> \>\> 8. Study device is intended to be used temporarily.\> \>\> 9. The patient has had \>2 previous arteriovenous accesses in treatment arm.\> \>\> 10. Patient is taking Aggrenox®.\> \>\> 11. The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.\> \>\> 12. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(\>10 mg), cyclosporine, tacrolimus or cyclophosphamide.\> \>\> 13. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\> \>\> 14. Life expectancy is less than 12 months.\> \>\> 15. The patient is pregnant.\> \>\> 16. The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Patency at 6 Months | 6 Months | Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month. |
| Freedom From Bleeding at 6 Months | 6 Months | Percentage of subjects free from both major and minor bleeding events, assessed at 6-months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Unassisted Patency at 6 Months | 6 Months | The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency. |
| Time to Event Analysis (Cumulative Patency) | 6 Months | The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring. |
| Time to First Cannulation | Time of access placement to first cannulation, assessed up to one week | The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft. |
| Time to Potential Central Venous Catheter Removal | Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123 | The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE® ACUSEAL Vascular Graft GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice. | 138 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Abandonment of study graft | 27 |
| Overall Study | Death | 17 |
Baseline characteristics
| Characteristic | GORE® ACUSEAL Vascular Graft |
|---|---|
| Age Continuous | 63 years STANDARD_DEVIATION 13.8 |
| Region of Enrollment United States | 138 participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 138 |
| serious Total, serious adverse events | 74 / 138 |
Outcome results
Primary
Cumulative Patency at 6 Months
Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.
Time frame: 6 Months
Population: All subjects with unknown cumulative patency status at the 6 month window were omitted from calculations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® ACUSEAL Vascular Graft | Cumulative Patency at 6 Months | 83.6 percentage of participants |
Primary
Freedom From Bleeding at 6 Months
Percentage of subjects free from both major and minor bleeding events, assessed at 6-months
Time frame: 6 Months
Population: All subjects with unknown bleeding status at the 6 month window were omitted from calculations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® ACUSEAL Vascular Graft | Freedom From Bleeding at 6 Months | 87.6 percentage of participants |
Secondary
Primary Unassisted Patency at 6 Months
The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency.
Time frame: 6 Months
Population: All subjects with unknown primary unassisted patency status at the 6 month window were omitted from calculations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® ACUSEAL Vascular Graft | Primary Unassisted Patency at 6 Months | 45 percentage of participants |
Secondary
Time to Event Analysis (Cumulative Patency)
The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring.
Time frame: 6 Months
Population: All subjects with unknown time to event analysis (cumulative patency) status at the 6 month window were omitted from calculations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® ACUSEAL Vascular Graft | Time to Event Analysis (Cumulative Patency) | 84.2 percentage of participants |
Secondary
Time to First Cannulation
The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.
Time frame: Time of access placement to first cannulation, assessed up to one week
Population: All subjects with unknown time to first cannulation at the 6 month window were omitted from calculations
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE® ACUSEAL Vascular Graft | Time to First Cannulation | Cannulated within 24 hours of procedure | 22.2 percentage of grafts |
| GORE® ACUSEAL Vascular Graft | Time to First Cannulation | Cannulated within 48 hours of procedure | 35.6 percentage of grafts |
| GORE® ACUSEAL Vascular Graft | Time to First Cannulation | Cannulated within 72 hours of procedure | 40.0 percentage of grafts |
| GORE® ACUSEAL Vascular Graft | Time to First Cannulation | Cannulated within 1 week of procedure | 51.9 percentage of grafts |
Secondary
Time to Potential Central Venous Catheter Removal
The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation.
Time frame: Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123
Population: All subjects with unknown time to potential central venous catheter removal at the 6 month window were omitted from calculations
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GORE® ACUSEAL Vascular Graft | Time to Potential Central Venous Catheter Removal | 15.5 days |