End Stage Renal Disease, Hemodialysis, Renal Failure, Vascular Access
Conditions
Brief summary
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
Detailed description
This is a Phase 3, prospective, multicenter, multinational, open-label, randomized, two-arm, comparative study. Subjects who sign informed consent would undergo study-specific screening assessments within 35 days from the day of informed consent. Participants who consented were randomized to the HAV treatment arm of one of the two commercially available comparators.
Interventions
BIOLOGICALHuman Acellular Vessel (HAV)
HAV-tissue-engineered vascular conduit (6mm diameter)
DEVICEePTFE graft
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Sponsors
Humacyte, Inc.
CTI Clinical Trial and Consulting Services
California Institute for Regenerative Medicine (CIRM)
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
* Subjects with ESRD who need placement of an AV graft in the arm. * Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation. * Suitable anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow). * Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 0 (within 35 days). * Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 35 days). * Adequate liver function prior to Day 0 (within 35 days). * Female subjects must be either: * Of non-childbearing potential Or * Must agree to use at least one form of birth control methods for the duration of the study. * Subject, or legal representative, able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits. * Life expectancy of at least 1 year.
Exclusion criteria
* History or evidence of severe peripheral vascular disease in the intended arm for implantation. * Known or suspected central vein stenosis or conduit occlusion on the ipsilateral side of planned implantation, unless the stenosis is corrected prior to study conduit implantation. * Treatment with any investigational drug or device within 60 days prior to study entry (Day 0). * Cancer that is actively being treated with a cytotoxic agent. * Documented hyper-coagulable state. * Bleeding diathesis. * Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression. * High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded. * Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded. * The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial: * tacrolimus or FK506 \[Prograf\] * mycophenolate mofetil \[Cellcept\], * cyclosporine \[Sandimmune or Gengraf\] i-Sirolimus administered systemically (Sirolimus in drug eluting stents is NOT an exclusion) * Anticipated renal transplant within 6 months. * Venous outflow from study conduit cannot be placed more centrally than the venous outflow of any previous failed access in that extremity. * Active local or systemic infection (white blood cells \[WBC\] \> 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least one week post resolution of that infection before implantation. * Known serious allergy to planned antiplatelet agent. * Pregnant women, or women intending to become pregnant during the course of the trial. * Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the study conduit. * Previous enrollment in this study or any other study with the HAV. * Employees of Humacyte and employees or relatives of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Loss of Secondary Patency | 12 months post-implantation | 1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Inner Diameter of Conduit (Millimeter) | 12 months post-implantation | Duplex ultrasonography: diameter of the mid-conduit lumen |
| Number of Participants With Loss of Primary Patency | 12 months post-implantation | Use of duplex ultrasonography to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed. |
| Study Conduit Abandonment | 24 months post-implantation | No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis. |
| Rate of Adjudicated Study Conduit Access Related Infections | 24 months post-implantation | Adjudicated using the standard definition of access-related infections (CDC; 2013). |
| Access-related Infections | 60 months post-implantation | Using Dialysis Event Surveillance Manual: CDC; 2013. |
| Participants With at Least 1 Intervention Required to Achieve/Maintain Secondary Patency | 24 months post-implantation | Rate of intervention defined as the number of interventions per participant per year while conduit is patent (i.e., has not been abandoned). Number of successful interventions to achieve/maintain Secondary Patency. |
| Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 6 Millimeters) | 60 months post-implantation | Total number of interventions performed by treatment group stratified by any use of balloon size no \> 6 millimeters. |
| Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 6 Millimeters) | 60 months post-implantation | Total number of interventions performed by treatment group stratified by any use of balloon size greater than 6 millimeters. |
| Thrombosis of Study Access That Required Intervention | 24 months post-implantation | Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access |
| Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects) | 2 to 18 Months post-implantation | Dialysis efficiency as assessed by spKt/Vurea (obtained from dialysis unit for a subset of subjects) will be summarized descriptively. The most recent available data prior to the study visits will be used for the analysis. Twenty sites provided at least 1 spKt/Vurea measurement. spKt/Vurea: measure of dialysis adequacy for a single hemodialysis treatment using the single pooled method. |
| Severity of Adverse Events | 24 months post-implantation | Severity Assessment Standard 1. Mild: Events require minimal or no treatment and do not interfere with the subject's daily activities. 2. Moderate: Events result in a low level of inconvenience or concern with the therapeutic measures. May cause some interference with functioning. 3. Severe: Events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating. 4. Life-threatening: Any adverse event that places the subject or participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death. 5. Death: Death related to Adverse Event. |
| Number of Participants With at Least One Adverse Event | 24 months post-implantation | Collection of all Adverse Events beginning on Day 0 after implantation up to 2 years post implantation (Month 24). |
| True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters) | 24 months post-implantation | Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline |
| Pseudoaneurysm Formation | 24 months post-implantation | Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms. |
| Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury | 24 months post-implantation | Assessed by ultrasound |
| Calculated Panel Reactive Antibody More Than 20% Change From Baseline | 18 months post-implantation | Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline |
| Anastomotic Bleeding or Rupture | 24 months post-implantation | Assessed by ultrasound |
Countries
Germany, Israel, Poland, Portugal, United Kingdom, United States
Contacts
STUDY_DIRECTORShamik Parikh, MD
Humacyte, Inc.
Participant flow
Recruitment details
This was a large multicenter comparative study conducted at 37 centers in 6 countries to compare the HAV and ePTFE.
Participants by arm
| Arm | Count |
|---|---|
| Human Acellular Vessel (HAV) HAV-tissue-engineered vascular conduit (6mm diameter) | 177 |
| ePTFE The comparator is one two commercially available 6 mm ePTFE grafts (Bard Impra® or Gore PROPATEN®) | 178 |
| Total | 355 |
Baseline characteristics
| Characteristic | Human Acellular Vessel (HAV) | ePTFE | Total |
|---|---|---|---|
| Age, Customized 18-21 years | 0 Age range of participants | 1 Age range of participants | 1 Age range of participants |
| Age, Customized 22-44 years | 21 Age range of participants | 22 Age range of participants | 43 Age range of participants |
| Age, Customized 45-64 years | 69 Age range of participants | 78 Age range of participants | 147 Age range of participants |
| Age, Customized 65-74 years | 57 Age range of participants | 50 Age range of participants | 107 Age range of participants |
| Age, Customized >/= 75 years | 30 Age range of participants | 27 Age range of participants | 57 Age range of participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 20 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 129 Participants | 127 Participants | 256 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 22 Participants | 31 Participants | 53 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Black or African American | 44 Participants | 49 Participants | 93 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 123 Participants | 116 Participants | 239 Participants |
| Region of Enrollment Europe | 62 participants | 61 participants | 123 participants |
| Region of Enrollment Israel | 12 participants | 14 participants | 26 participants |
| Region of Enrollment United States | 103 participants | 103 participants | 206 participants |
| Sex: Female, Male Female | 89 Participants | 90 Participants | 179 Participants |
| Sex: Female, Male Male | 88 Participants | 88 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 46 / 177 | 39 / 178 |
| other Total, other adverse events | 176 / 177 | 176 / 178 |
| serious Total, serious adverse events | 157 / 177 | 146 / 178 |
Outcome results
Primary
Number of Participants With Loss of Secondary Patency
1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. Abandonment defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).
Time frame: 24 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Number of Participants With Loss of Secondary Patency | 48 Participants |
| ePTFE | Number of Participants With Loss of Secondary Patency | 41 Participants |
Primary
Number of Participants With Loss of Secondary Patency
1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. Abandonment defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).
Time frame: 12 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Number of Participants With Loss of Secondary Patency | 29 Participants |
| ePTFE | Number of Participants With Loss of Secondary Patency | 34 Participants |
Primary
Number of Participants With Loss of Secondary Patency
1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. Abandonment defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).
Time frame: 18 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Number of Participants With Loss of Secondary Patency | 41 Participants |
| ePTFE | Number of Participants With Loss of Secondary Patency | 37 Participants |
Secondary
Access-related Infections
Using Dialysis Event Surveillance Manual: CDC; 2013.
Time frame: 60 months post-implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Acellular Vessel (HAV) | Access-related Infections | 17 Access related infection events |
| ePTFE | Access-related Infections | 27 Access related infection events |
Secondary
Anastomotic Bleeding or Rupture
Assessed by ultrasound
Time frame: 60 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Anastomotic Bleeding or Rupture | 0 Participants |
| ePTFE | Anastomotic Bleeding or Rupture | 0 Participants |
Secondary
Anastomotic Bleeding or Rupture
Assessed by ultrasound
Time frame: 24 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Anastomotic Bleeding or Rupture | 0 Participants |
| ePTFE | Anastomotic Bleeding or Rupture | 0 Participants |
Secondary
Calculated Panel Reactive Antibody More Than 20% Change From Baseline
Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline
Time frame: 18 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Calculated Panel Reactive Antibody More Than 20% Change From Baseline | 3 Participants |
| ePTFE | Calculated Panel Reactive Antibody More Than 20% Change From Baseline | 8 Participants |
Secondary
Calculated Panel Reactive Antibody More Than 20% Change From Baseline
Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline
Time frame: 24 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Calculated Panel Reactive Antibody More Than 20% Change From Baseline | 2 Participants |
| ePTFE | Calculated Panel Reactive Antibody More Than 20% Change From Baseline | 10 Participants |
Secondary
Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects)
Dialysis efficiency as assessed by spKt/Vurea (obtained from dialysis unit for a subset of subjects) will be summarized descriptively. The most recent available data prior to the study visits will be used for the analysis. Twenty sites provided at least 1 spKt/Vurea measurement. spKt/Vurea: measure of dialysis adequacy for a single hemodialysis treatment using the single pooled method.
Time frame: 2 to 18 Months post-implantation
Population: Female and Male
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Human Acellular Vessel (HAV) | Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects) | 1.61 unitless | Standard Deviation 0.551 |
| ePTFE | Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects) | 1.67 unitless | Standard Deviation 0.445 |
Secondary
Mean Inner Diameter of Conduit (Millimeter)
Duplex ultrasonography: diameter of the mid-conduit lumen
Time frame: 24 months post-implantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Human Acellular Vessel (HAV) | Mean Inner Diameter of Conduit (Millimeter) | 6.02 Inner diameter (millimeter) | Standard Deviation 2.898 |
| ePTFE | Mean Inner Diameter of Conduit (Millimeter) | 5.88 Inner diameter (millimeter) | Standard Deviation 2.209 |
Secondary
Mean Inner Diameter of Conduit (Millimeter)
Duplex ultrasonography: diameter of the mid-conduit lumen
Time frame: 12 months post-implantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Human Acellular Vessel (HAV) | Mean Inner Diameter of Conduit (Millimeter) | 6.20 Inner diameter (millimeter) | Standard Deviation 1.452 |
| ePTFE | Mean Inner Diameter of Conduit (Millimeter) | 5.66 Inner diameter (millimeter) | Standard Deviation 1.601 |
Secondary
Mean Inner Diameter of Conduit (Millimeter)
Duplex ultrasonography: diameter of the mid-conduit lumen
Time frame: 60 months post-implantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Human Acellular Vessel (HAV) | Mean Inner Diameter of Conduit (Millimeter) | 6.19 Inner diameter (millimeter) | Standard Deviation 1.979 |
| ePTFE | Mean Inner Diameter of Conduit (Millimeter) | 6.23 Inner diameter (millimeter) | Standard Deviation 1.131 |
Secondary
Number of Participants With at Least One Adverse Event
Collection of all Adverse Events beginning on Day 0 after implantation up to 2 years post implantation (Month 24).
Time frame: 24 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Number of Participants With at Least One Adverse Event | 175 Participants |
| ePTFE | Number of Participants With at Least One Adverse Event | 174 Participants |
Secondary
Number of Participants With Loss of Primary Patency
Use of duplex ultrasonography to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.
Time frame: 12 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Number of Participants With Loss of Primary Patency | 118 Participants |
| ePTFE | Number of Participants With Loss of Primary Patency | 78 Participants |
Secondary
Number of Participants With Loss of Primary Patency
Use of duplex ultrasonography to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.
Time frame: 24 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Number of Participants With Loss of Primary Patency | 132 Participants |
| ePTFE | Number of Participants With Loss of Primary Patency | 104 Participants |
Secondary
Number of Participants With Loss of Primary Patency
Duplex ultrasound was used to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.
Time frame: 60 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Number of Participants With Loss of Primary Patency | 146 Participants |
| ePTFE | Number of Participants With Loss of Primary Patency | 121 Participants |
Secondary
Number of Participants With Loss of Primary Patency
Use of duplex ultrasonography to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.
Time frame: 18 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Number of Participants With Loss of Primary Patency | 146 Participants |
| ePTFE | Number of Participants With Loss of Primary Patency | 111 Participants |
Secondary
Participants With at Least 1 Intervention Required to Achieve/Maintain Secondary Patency
Rate of intervention defined as the number of interventions per participant per year while conduit is patent (i.e., has not been abandoned). Number of successful interventions to achieve/maintain Secondary Patency.
Time frame: 24 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Participants With at Least 1 Intervention Required to Achieve/Maintain Secondary Patency | 146 Participants |
| ePTFE | Participants With at Least 1 Intervention Required to Achieve/Maintain Secondary Patency | 116 Participants |
Secondary
Pseudoaneurysm Formation
Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms.
Time frame: 24 months post-implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Acellular Vessel (HAV) | Pseudoaneurysm Formation | 98 Pseudoaneurysms |
| ePTFE | Pseudoaneurysm Formation | 47 Pseudoaneurysms |
Secondary
Pseudoaneurysm Formation
Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms.
Time frame: 60 months post-implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Acellular Vessel (HAV) | Pseudoaneurysm Formation | 113 Pseudoaneurysms |
| ePTFE | Pseudoaneurysm Formation | 59 Pseudoaneurysms |
Secondary
Rate of Adjudicated Study Conduit Access Related Infections
Adjudicated using the standard definition of access-related infections (CDC; 2013).
Time frame: 24 months post-implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Acellular Vessel (HAV) | Rate of Adjudicated Study Conduit Access Related Infections | 0.93 Events per 100 Person-Years |
| ePTFE | Rate of Adjudicated Study Conduit Access Related Infections | 4.54 Events per 100 Person-Years |
Secondary
Severity of Adverse Events
Severity Assessment Standard 1. Mild: Events require minimal or no treatment and do not interfere with the subject's daily activities. 2. Moderate: Events result in a low level of inconvenience or concern with the therapeutic measures. May cause some interference with functioning. 3. Severe: Events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating. 4. Life-threatening: Any adverse event that places the subject or participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death. 5. Death: Death related to Adverse Event.
Time frame: 24 months post-implantation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Human Acellular Vessel (HAV) | Severity of Adverse Events | Moderate | 39 Participants |
| Human Acellular Vessel (HAV) | Severity of Adverse Events | Life-threatening | 9 Participants |
| Human Acellular Vessel (HAV) | Severity of Adverse Events | Severe | 74 Participants |
| Human Acellular Vessel (HAV) | Severity of Adverse Events | Death | 45 Participants |
| Human Acellular Vessel (HAV) | Severity of Adverse Events | Mild | 8 Participants |
| ePTFE | Severity of Adverse Events | Death | 39 Participants |
| ePTFE | Severity of Adverse Events | Mild | 9 Participants |
| ePTFE | Severity of Adverse Events | Moderate | 55 Participants |
| ePTFE | Severity of Adverse Events | Severe | 64 Participants |
| ePTFE | Severity of Adverse Events | Life-threatening | 7 Participants |
Secondary
Study Conduit Abandonment
No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.
Time frame: 24 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Study Conduit Abandonment | 57 Participants |
| ePTFE | Study Conduit Abandonment | 44 Participants |
Secondary
Study Conduit Abandonment
No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.
Time frame: 60 months post-implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Human Acellular Vessel (HAV) | Study Conduit Abandonment | 69 Participants |
| ePTFE | Study Conduit Abandonment | 53 Participants |
Secondary
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury
Assessed by ultrasound
Time frame: 24 months post-implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Acellular Vessel (HAV) | Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury | 0 Ruptures d/t iatrogenic injury |
| ePTFE | Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury | 0 Ruptures d/t iatrogenic injury |
Secondary
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury
Assessed by ultrasound
Time frame: 60 months post-implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Acellular Vessel (HAV) | Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury | 0 Ruptures d/t iatrogenic injury |
| ePTFE | Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury | 0 Ruptures d/t iatrogenic injury |
Secondary
Thrombosis of Study Access That Required Intervention
Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access
Time frame: 24 months post-implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Acellular Vessel (HAV) | Thrombosis of Study Access That Required Intervention | 361 Thrombosis events requiring intervention |
| ePTFE | Thrombosis of Study Access That Required Intervention | 170 Thrombosis events requiring intervention |
Secondary
Thrombosis of Study Access That Required Intervention
Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access
Time frame: 60 months post-implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Acellular Vessel (HAV) | Thrombosis of Study Access That Required Intervention | 409 Thrombosis events requiring intervention |
| ePTFE | Thrombosis of Study Access That Required Intervention | 205 Thrombosis events requiring intervention |
Secondary
Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 6 Millimeters)
Total number of interventions performed by treatment group stratified by any use of balloon size no \> 6 millimeters.
Time frame: 60 months post-implantation
Population: Non-oversized ballon use (no greater than 6 mm)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Human Acellular Vessel (HAV) | Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 6 Millimeters) | 2.7 Interventions per participant | Standard Deviation 3.68 |
| ePTFE | Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 6 Millimeters) | 2.7 Interventions per participant | Standard Deviation 3.77 |
Secondary
Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 6 Millimeters)
Total number of interventions performed by treatment group stratified by any use of balloon size greater than 6 millimeters.
Time frame: 60 months post-implantation
Population: Oversized ballon use (greater than 6 mm)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Human Acellular Vessel (HAV) | Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 6 Millimeters) | 7.3 Interventions per participant | Standard Deviation 5.74 |
| ePTFE | Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 6 Millimeters) | 2.7 Interventions per participant | Standard Deviation 3.77 |
Secondary
True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)
Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline
Time frame: 24 months post-implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Acellular Vessel (HAV) | True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters) | 19 Total number of aneurysms |
| ePTFE | True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters) | 11 Total number of aneurysms |
Secondary
True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)
Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline
Time frame: 60 months post-implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Human Acellular Vessel (HAV) | True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters) | 23 Total number of aneurysms |
| ePTFE | True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters) | 12 Total number of aneurysms |