Trial Outcomes & Findings for Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study (NCT NCT00890045)
NCT ID: NCT00890045
Last Updated: 2024-01-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
6 months, 12 months
Results posted on
2024-01-29
Participant Flow
Participant milestones
| Measure |
Control Graft
Conventional ePTFE hemodialysis graft
|
HeRO Vascular Access Device
HeRO Vascular Access Device: HeRO Vascular Access Device
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
52
|
|
Overall Study
COMPLETED
|
15
|
42
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
| Measure |
Control Graft
Conventional ePTFE hemodialysis graft
|
HeRO Vascular Access Device
HeRO Vascular Access Device: HeRO Vascular Access Device
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Did not receive HeRO Graft
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
Baseline Characteristics
Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study
Baseline characteristics by cohort
| Measure |
Control Group
n=20 Participants
Conventional Arteriovenous ePTFE Graft Recipients
|
HeRO Group
n=52 Participants
HeRO Graft Recipients
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
52 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
History of Coronary artery disease
Yes
|
15 participants
n=5 Participants
|
39 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
History of Coronary artery disease
No
|
5 participants
n=5 Participants
|
13 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
History of Diabetes mellitus
Yes
|
14 participants
n=5 Participants
|
34 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
History of Diabetes mellitus
No
|
6 participants
n=5 Participants
|
18 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
History of Hypertension
Yes
|
19 participants
n=5 Participants
|
49 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
History of Hypertension
No
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Access History
De Novo Access
|
5 participants
n=5 Participants
|
19 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Access History
Re do Access
|
15 participants
n=5 Participants
|
33 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control Group
n=19 Participants
Conventional Arteriovenous ePTFE Graft Recipients
|
HeRO Group
n=49 Participants
HeRO Graft Recipients
|
|---|---|---|
|
Percentage of Patients With Primary Patency
6 Months
|
48.2 percentage of participants patent
Interval 25.1 to 68.0
|
47.0 percentage of participants patent
Interval 32.7 to 60.1
|
|
Percentage of Patients With Primary Patency
12 Months
|
30.6 percentage of participants patent
Interval 11.8 to 51.9
|
34.8 percentage of participants patent
Interval 21.9 to 48.0
|
PRIMARY outcome
Timeframe: 6 months, 12 monthsPopulation: The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date.
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.
Outcome measures
| Measure |
Control Group
n=15 Participants
Conventional Arteriovenous ePTFE Graft Recipients
|
HeRO Group
n=36 Participants
HeRO Graft Recipients
|
|---|---|---|
|
Percentage of Patients With Assisted Primary Patency
6 Months
|
88.8 percentage of participants patent
Interval 62.1 to 97.1
|
86.2 percentage of participants patent
Interval 71.7 to 93.6
|
|
Percentage of Patients With Assisted Primary Patency
12 Months
|
75.2 percentage of participants patent
Interval 46.1 to 90.0
|
79.8 percentage of participants patent
Interval 63.1 to 89.5
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date.
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.
Outcome measures
| Measure |
Control Group
n=19 Participants
Conventional Arteriovenous ePTFE Graft Recipients
|
HeRO Group
n=45 Participants
HeRO Graft Recipients
|
|---|---|---|
|
Percentage of Patients With Secondary Patency
6 Months
|
58.4 percentage of participants patent
Interval 33.8 to 76.7
|
76.7 percentage of participants patent
Interval 61.8 to 86.4
|
|
Percentage of Patients With Secondary Patency
12 Months
|
58.4 percentage of participants patent
Interval 33.8 to 76.7
|
67.6 percentage of participants patent
Interval 52.0 to 79.1
|
PRIMARY outcome
Timeframe: 12 monthsSerious 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.
Outcome measures
| Measure |
Control Group
n=20 Participants
Conventional Arteriovenous ePTFE Graft Recipients
|
HeRO Group
n=52 Participants
HeRO Graft Recipients
|
|---|---|---|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Other
|
2 participants
|
5 participants
|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Bleeding, hemorrhage or hematoma
|
0 participants
|
6 participants
|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Death
|
0 participants
|
1 participants
|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Device technical failure
|
0 participants
|
1 participants
|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Embolism
|
0 participants
|
2 participants
|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Heart failure
|
1 participants
|
0 participants
|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Infection (non-BSIe)
|
2 participants
|
2 participants
|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Site pain
|
0 participants
|
1 participants
|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Trauma to major veins, arteries, nerves
|
0 participants
|
1 participants
|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Steal syndrome
|
1 participants
|
2 participants
|
|
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Device/Implant procedure-related Bloodstream Infec
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date.
Reported as Mean Kt/V, K= dialyzer clearance of urea, t= dialysis time, V=subject total body water
Outcome measures
| Measure |
Control Group
n=10 Participants
Conventional Arteriovenous ePTFE Graft Recipients
|
HeRO Group
n=33 Participants
HeRO Graft Recipients
|
|---|---|---|
|
Adequacy of Dialysis
|
1.7 Kt/V
Standard Deviation 0.4
|
1.6 Kt/V
Standard Deviation 0.3
|
Adverse Events
Control Group
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
HeRO Group
Serious events: 19 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=20 participants at risk
Conventional Arteriovenous ePTFE Graft Recipients
|
HeRO Group
n=52 participants at risk
HeRO Graft Recipients
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding, hemorrhage or hematoma
|
0.00%
0/20 • 1 year
|
11.5%
6/52 • Number of events 6 • 1 year
|
|
General disorders
Death
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Device technical failure
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Embolism
|
0.00%
0/20 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
Cardiac disorders
Heart failure
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 2 • 1 year
|
|
Infections and infestations
Infection (non-BSI)
|
10.0%
2/20 • Number of events 2 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
General disorders
Other
|
10.0%
2/20 • Number of events 2 • 1 year
|
9.6%
5/52 • Number of events 8 • 1 year
|
|
General disorders
Site pain
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Nervous system disorders
Trauma to major veins, arteries, nerves
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Steal syndrome
|
5.0%
1/20 • Number of events 1 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
Other adverse events
| Measure |
Control Group
n=20 participants at risk
Conventional Arteriovenous ePTFE Graft Recipients
|
HeRO Group
n=52 participants at risk
HeRO Graft Recipients
|
|---|---|---|
|
Cardiac disorders
Right Atrial Clot
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension with fever
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Cardiac disorders
non-sustained mild and ventricular tachycardia
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Cardiac disorders
cardiogenic shock
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
hypoxia
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.00%
0/20 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
hypoxemia
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
elevated white blood cell count
|
0.00%
0/20 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Vascular disorders
symptomatic central venous stenosis
|
20.0%
4/20 • Number of events 4 • 1 year
|
0.00%
0/52 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place