Renal Failure Chronic Requiring Hemodialysis
Conditions
Keywords
Vascular access hemodialysis, ePTFE graft, Graft-eligible, Long-term vascular access for hemodialysis
Brief summary
Compare the HeRO Vascular Access Device to a conventional ePTFE graft.
Detailed description
The purpose of this study is to compare the HeRO Vascular Access Device to a conventional ePTFE graft. It is hypothesized that HeRO patency will be comparable to the conventional ePTFE graft control.
Interventions
HeRO Vascular Access Device
DEVICEConventional ePTFE hemodialysis graft
Conventional ePTFE hemodialysis graft
Sponsors
CryoLife, Inc.
Merit Medical Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. 22 years of age or older. 2. Male or non-pregnant female. 3. Life expectancy 2 years. 4. End-stage renal disease requiring an arm vascular prosthesis for dialysis access. 5. Ability to understand and provide written informed consent. 6. Willing and able to cooperate with follow-up examinations. 7. Subject's upper arm can be used for implant (Note: The GVAS device must be implanted in the upper arm only, but the Control group graft can be implanted in the upper or lower arm location.). 8. Able to follow a daily aspirin and/or other oral anticoagulation/antiplatelet regimen.
Exclusion criteria
1. Potential graft target artery less than 3 mm in diameter determined by any suitable preoperative measure. 2. Documented history of drug abuse within six months. 3. Planned concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures. 4. Currently being treated with another investigational device or drug. 5. Known bleeding diathesis or hypercoagulable state. 6. Peripheral white blood cell count 1500/mm3 (1.5 K/mm3) or platelet counts 50,000/mm3 (50 K/mm3). 7. Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be included. 8. Subjects with known or suspected concomitant bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B may be included. Subjects who are HIV + with CD4 count of \<200 are excluded. 9. Severe underlying co-morbidity or immediate life-threatening condition. 10. Subjects with any condition which, in the opinion of the investigator, could preclude evaluation of response or completion of follow-up or affect subject safety. 11. Subjects who are candidates for autologous fistulas. 12. Subjects with scheduled renal transplant within the next 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Primary Patency | 6 months, 12 months | Primary patency was defined as the interval of time from access placement until any intervention designed to maintain or reestablish patency, access thrombosis, or the time of measurement of patency. |
| Percentage of Patients With Assisted Primary Patency | 6 months, 12 months | Assisted primary patency was defined as the interval of time from access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (i.e., surgical or endovascular interventions) designed to maintain the functionality of a patent access. |
| Percentage of Patients With Secondary Patency | 12 months | Secondary patency was defined as the interval of time from access placement until access abandonment, thrombosis, or the time of patency measurements including intervening surgical or endovascular interventions designed to reestablish functionality in a thrombosed access. |
| Number of Patients With Serious Device or Implant Procedure-related Adverse Events | 12 months | Serious adverse events were defined as events that required hospitalization ≥24 hours, prolonged an existing hospitalization, resulted in persistent or significant disability or incapacity, were considered life-threatening, or resulted in death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of Dialysis | 12 months | Reported as Mean Kt/V, K= dialyzer clearance of urea, t= dialysis time, V=subject total body water |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Conventional Arteriovenous ePTFE Graft Recipients | 20 |
| HeRO Group HeRO Graft Recipients | 52 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Did not receive HeRO Graft | 0 | 2 |
| Overall Study | Lost to Follow-up | 5 | 7 |
Baseline characteristics
| Characteristic | Total | HeRO Group | Control Group |
|---|---|---|---|
| Access History De Novo Access | 24 participants | 19 participants | 5 participants |
| Access History Re do Access | 48 participants | 33 participants | 15 participants |
| Age, Continuous | 63.8 years STANDARD_DEVIATION 13 | 62.9 years STANDARD_DEVIATION 12.5 | 66.1 years STANDARD_DEVIATION 13.5 |
| History of Coronary artery disease No | 18 participants | 13 participants | 5 participants |
| History of Coronary artery disease Yes | 54 participants | 39 participants | 15 participants |
| History of Diabetes mellitus No | 24 participants | 18 participants | 6 participants |
| History of Diabetes mellitus Yes | 48 participants | 34 participants | 14 participants |
| History of Hypertension No | 4 participants | 3 participants | 1 participants |
| History of Hypertension Yes | 68 participants | 49 participants | 19 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 24 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 7 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 21 Participants | 5 Participants |
| Region of Enrollment United States | 72 participants | 52 participants | 20 participants |
| Sex: Female, Male Female | 38 Participants | 28 Participants | 10 Participants |
| Sex: Female, Male Male | 34 Participants | 24 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 20 | 5 / 52 |
| serious Total, serious adverse events | 5 / 20 | 19 / 52 |
Outcome results
Primary
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Serious adverse events were defined as events that required hospitalization ≥24 hours, prolonged an existing hospitalization, resulted in persistent or significant disability or incapacity, were considered life-threatening, or resulted in death.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Heart failure | 1 participants |
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Site pain | 0 participants |
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Embolism | 0 participants |
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Trauma to major veins, arteries, nerves | 0 participants |
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Steal syndrome | 1 participants |
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Infection (non-BSIe) | 2 participants |
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Device/Implant procedure-related Bloodstream Infec | 1 participants |
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Device technical failure | 0 participants |
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Bleeding, hemorrhage or hematoma | 0 participants |
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Other | 2 participants |
| Control Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Death | 0 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Other | 5 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Death | 1 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Device technical failure | 1 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Embolism | 2 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Heart failure | 0 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Infection (non-BSIe) | 2 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Trauma to major veins, arteries, nerves | 1 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Site pain | 1 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Steal syndrome | 2 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Device/Implant procedure-related Bloodstream Infec | 3 participants |
| HeRO Group | Number of Patients With Serious Device or Implant Procedure-related Adverse Events | Bleeding, hemorrhage or hematoma | 6 participants |
Primary
Percentage of Patients With Assisted Primary Patency
Assisted primary patency was defined as the interval of time from access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (i.e., surgical or endovascular interventions) designed to maintain the functionality of a patent access.
Time frame: 6 months, 12 months
Population: The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Percentage of Patients With Assisted Primary Patency | 6 Months | 88.8 percentage of participants patent |
| Control Group | Percentage of Patients With Assisted Primary Patency | 12 Months | 75.2 percentage of participants patent |
| HeRO Group | Percentage of Patients With Assisted Primary Patency | 6 Months | 86.2 percentage of participants patent |
| HeRO Group | Percentage of Patients With Assisted Primary Patency | 12 Months | 79.8 percentage of participants patent |
Primary
Percentage of Patients With Primary Patency
Primary patency was defined as the interval of time from access placement until any intervention designed to maintain or reestablish patency, access thrombosis, or the time of measurement of patency.
Time frame: 6 months, 12 months
Population: The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date. Note: Of the 52 subjects randomized to the HeRO Graft, 50 subjects were successfully implanted. Two implants were abandoned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Percentage of Patients With Primary Patency | 6 Months | 48.2 percentage of participants patent |
| Control Group | Percentage of Patients With Primary Patency | 12 Months | 30.6 percentage of participants patent |
| HeRO Group | Percentage of Patients With Primary Patency | 6 Months | 47.0 percentage of participants patent |
| HeRO Group | Percentage of Patients With Primary Patency | 12 Months | 34.8 percentage of participants patent |
Primary
Percentage of Patients With Secondary Patency
Secondary patency was defined as the interval of time from access placement until access abandonment, thrombosis, or the time of patency measurements including intervening surgical or endovascular interventions designed to reestablish functionality in a thrombosed access.
Time frame: 12 months
Population: The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Percentage of Patients With Secondary Patency | 6 Months | 58.4 percentage of participants patent |
| Control Group | Percentage of Patients With Secondary Patency | 12 Months | 58.4 percentage of participants patent |
| HeRO Group | Percentage of Patients With Secondary Patency | 6 Months | 76.7 percentage of participants patent |
| HeRO Group | Percentage of Patients With Secondary Patency | 12 Months | 67.6 percentage of participants patent |
Secondary
Adequacy of Dialysis
Reported as Mean Kt/V, K= dialyzer clearance of urea, t= dialysis time, V=subject total body water
Time frame: 12 months
Population: The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Adequacy of Dialysis | 1.7 Kt/V | Standard Deviation 0.4 |
| HeRO Group | Adequacy of Dialysis | 1.6 Kt/V | Standard Deviation 0.3 |