A Phase 3 interventional study of Human Acellular Vessel (HAV) and ePTFE graft in Renal Failure, End Stage Renal Disease and Hemodialysis, sponsored by Humacyte, Inc.. Completed at 38 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Humacyte, Inc. · Phase 3, Interventional, and Treatment
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 355 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Humacyte, Inc. is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Compared within Kidney Failure, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Renal Insufficiency. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female subjects must be either:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HAV-tissue-engineered vascular conduit (6mm diameter)
Biological: Human Acellular Vessel (HAV)
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Device: ePTFE graft
HAV-tissue-engineered vascular conduit (6mm diameter)
Also known as: (regulated as a biological product)
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
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
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
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
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
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
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
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
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
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
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
Access-related Infections
Using Dialysis Event Surveillance Manual: CDC; 2013.
Time frame: 60 months post-implantation
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
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
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
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
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
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
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
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
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
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
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
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
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury
Assessed by ultrasound
Time frame: 24 months post-implantation
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury
Assessed by ultrasound
Time frame: 60 months post-implantation
Anastomotic Bleeding or Rupture
Assessed by ultrasound
Time frame: 24 months post-implantation
Anastomotic Bleeding or Rupture
Assessed by ultrasound
Time frame: 60 months post-implantation
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
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
Mean Inner Diameter of Conduit (Millimeter)
Duplex ultrasonography: diameter of the mid-conduit lumen
Time frame: 12 months post-implantation
Mean Inner Diameter of Conduit (Millimeter)
Duplex ultrasonography: diameter of the mid-conduit lumen
Time frame: 24 months post-implantation
Mean Inner Diameter of Conduit (Millimeter)
Duplex ultrasonography: diameter of the mid-conduit lumen
Time frame: 60 months post-implantation
Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 6-month follow-up period, evaluated across the Female Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 6 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
Time frame: 6 months from time of implantation
Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 12-month follow-up period, evaluated across the Female Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
Time frame: 12 months from time of implantation
Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 18-month follow-up period, evaluated across the Female Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 18 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
Time frame: 18 months from time of implantation
Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 24-month follow-up period, evaluated across the Female Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 24 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
Time frame: 24 months from time of implantation
This was a large multicenter comparative study conducted at 37 centers in 6 countries to compare the HAV and ePTFE.
| Milestone | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Started | 177 | 178 |
| Completed | 128 | 126 |
| Not completed | 49 | 52 |
| Withdrew: Subjects lost graft during the study up to the data cut-off | 49 | 52 |
| Milestone | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Started | 177 | 178 |
| Completed | 108 | 106 |
| Not completed | 69 | 72 |
| Milestone | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Started | 177 | 178 |
| Completed | 78 | 80 |
| Not completed | 99 | 98 |
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).
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Number of Participants With Loss of Secondary Patency | 29 | 34 |
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).
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Number of Participants With Loss of Secondary Patency | 41 | 37 |
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).
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Number of Participants With Loss of Secondary Patency | 48 | 41 |
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.
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Number of Participants With Loss of Primary Patency | 118 | 78 |
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.
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Number of Participants With Loss of Primary Patency | 146 | 111 |
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.
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Number of Participants With Loss of Primary Patency | 132 | 104 |
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.
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Number of Participants With Loss of Primary Patency | 146 | 121 |
No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Study Conduit Abandonment | 57 | 44 |
No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Study Conduit Abandonment | 69 | 53 |
Adjudicated using the standard definition of access-related infections (CDC; 2013).
| Events per 100 Person-Years | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Rate of Adjudicated Study Conduit Access Related Infections | 0.93 | 4.54 |
Using Dialysis Event Surveillance Manual: CDC; 2013.
| Access related infection events | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Access-related Infections | 17 | 27 |
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.
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Participants With at Least 1 Intervention Required to Achieve/Maintain Secondary Patency | 146 | 116 |
Total number of interventions performed by treatment group stratified by any use of balloon size no \> 6 millimeters.
| Interventions per participant | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 6 Millimeters) | 2.7 ± 3.68 | 2.7 ± 3.77 |
Total number of interventions performed by treatment group stratified by any use of balloon size greater than 6 millimeters.
| Interventions per participant | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 6 Millimeters) | 7.3 ± 5.74 | 2.7 ± 3.77 |
Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access
| Thrombosis events requiring intervention | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Thrombosis of Study Access That Required Intervention | 361 | 170 |
Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access
| Thrombosis events requiring intervention | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Thrombosis of Study Access That Required Intervention | 409 | 205 |
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.
| unitless | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects) | 1.61 ± 0.551 | 1.67 ± 0.445 |
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.
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Mild | 8 | 9 |
| Moderate | 39 | 55 |
| Severe | 74 | 64 |
| Life-threatening | 9 | 7 |
| Death | 45 | 39 |
Collection of all Adverse Events beginning on Day 0 after implantation up to 2 years post implantation (Month 24).
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Number of Participants With at Least One Adverse Event | 175 | 174 |
Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline
| Total number of aneurysms | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters) | 19 | 11 |
Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline
| Total number of aneurysms | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters) | 23 | 12 |
Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms.
| Pseudoaneurysms | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Pseudoaneurysm Formation | 98 | 47 |
Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms.
| Pseudoaneurysms | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Pseudoaneurysm Formation | 113 | 59 |
Assessed by ultrasound
| Ruptures d/t iatrogenic injury | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury | 0 | 0 |
Assessed by ultrasound
| Ruptures d/t iatrogenic injury | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury | 0 | 0 |
Assessed by ultrasound
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Anastomotic Bleeding or Rupture | 0 | 0 |
Assessed by ultrasound
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Anastomotic Bleeding or Rupture | 0 | 0 |
Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Calculated Panel Reactive Antibody More Than 20% Change From Baseline | 3 | 8 |
Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline
| Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Calculated Panel Reactive Antibody More Than 20% Change From Baseline | 2 | 10 |
Duplex ultrasonography: diameter of the mid-conduit lumen
| Inner diameter (millimeter) | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Mean Inner Diameter of Conduit (Millimeter) | 6.20 ± 1.452 | 5.66 ± 1.601 |
Duplex ultrasonography: diameter of the mid-conduit lumen
| Inner diameter (millimeter) | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Mean Inner Diameter of Conduit (Millimeter) | 6.02 ± 2.898 | 5.88 ± 2.209 |
Duplex ultrasonography: diameter of the mid-conduit lumen
| Inner diameter (millimeter) | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Mean Inner Diameter of Conduit (Millimeter) | 6.19 ± 1.979 | 6.23 ± 1.131 |
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 6-month follow-up period, evaluated across the Female Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 6 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
| Percentage of Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup | 89.4 (80.7 to 94.4) | 85.4 (76.2 to 91.3) |
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 12-month follow-up period, evaluated across the Female Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
| Percentage of Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup | 81.6 (71.3 to 88.5) | 78.5 (68.4 to 85.7) |
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 18-month follow-up period, evaluated across the Female Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 18 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
| Percentage of Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup | 75.9 (64.7 to 83.9) | 74.1 (63.2 to 82.2) |
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 24-month follow-up period, evaluated across the Female Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 24 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
| Percentage of Participants | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup | 72.9 (61.4 to 81.5) | 72.4 (61.2 to 80.8) |
Collected over All study participants were followed to 24 months post-implantation at routine study visits regardless of patency status. After 24 months, participants with a patent study conduit were followed (while the study conduit remained patent) for up to 5 years (60 months) post-implantation at routine study visits.. Non-serious events are listed at a 1.4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Human Acellular Vessel (HAV) | 46/177 (26%) | 157/177 (88.7%) | 176/177 (99.4%) |
| ePTFE | 39/178 (21.9%) | 146/178 (82%) | 176/178 (98.9%) |
| Event | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Vascular access site thrombosisInjury, poisoning and procedural complications | 81/177 | 57/178 |
| Vascular stenosisVascular disorders | 53/177 | 49/178 |
| PneumoniaInfections and infestations | 11/177 | 18/178 |
| Vascular access site infectionInfections and infestations | 13/177 | 18/178 |
| Vascular access site pseudoaneurysmInjury, poisoning and procedural complications | 17/177 | 5/178 |
| SepsisInfections and infestations | 13/177 | 12/178 |
| Cardiac arrestCardiac disorders | 6/177 | 11/178 |
| HypotensionVascular disorders | 10/177 | 4/178 |
| AnemiaBlood and lymphatic system disorders | 7/177 | 10/178 |
| HyperkalemiaMetabolism and nutrition disorders | 9/177 | 9/178 |
| Event | Human Acellular Vessel (HAV) | ePTFE |
|---|---|---|
| Vascular stenosisVascular disorders | 139/177 | 123/178 |
| Vascular access site thrombosisInjury, poisoning and procedural complications | 124/177 | 93/178 |
| Vascular access site pseudoaneurysmInjury, poisoning and procedural complications | 75/177 | 41/178 |
| Vascular access site hematomaInjury, poisoning and procedural complications | 48/177 | 37/178 |
| Vascular access site hemorrhageInjury, poisoning and procedural complications | 43/177 | 35/178 |
| Vascular access site swellingInjury, poisoning and procedural complications | 28/177 | 21/178 |
| Venous stenosisVascular disorders | 24/177 | 28/178 |
| Vascular access site infectionInfections and infestations | 17/177 | 27/178 |
| HyperkalemiaMetabolism and nutrition disorders | 25/177 | 26/178 |
| HypotensionVascular disorders | 23/177 | 12/178 |
| Age, Customized(Age range of participants) | Human Acellular Vessel (HAV) | ePTFE | Total |
|---|---|---|---|
| 18-21 years | 0 | 1 | 1 |
| 22-44 years | 21 | 22 | 43 |
| 45-64 years | 69 | 78 | 147 |
| 65-74 years | 57 | 50 | 107 |
| >/= 75 years | 30 | 27 | 57 |
| Sex: Female, Male(Participants) | Human Acellular Vessel (HAV) | ePTFE | Total |
|---|---|---|---|
| Female | 89 | 90 | 179 |
| Male | 88 | 88 | 176 |
| Ethnicity (NIH/OMB)(Participants) | Human Acellular Vessel (HAV) | ePTFE | Total |
|---|---|---|---|
| Hispanic or Latino | 26 | 20 | 46 |
| Not Hispanic or Latino | 129 | 127 | 256 |
| Unknown or Not Reported | 22 | 31 | 53 |
| Race/Ethnicity, Customized(Participants) | Human Acellular Vessel (HAV) | ePTFE | Total |
|---|---|---|---|
| White | 123 | 116 | 239 |
| Black or African American | 44 | 49 | 93 |
| Asian | 4 | 6 | 10 |
| American Indian or Alaska Native | 4 | 3 | 7 |
| Other | 2 | 4 | 6 |
| Region of Enrollment(participants) | Human Acellular Vessel (HAV) | ePTFE | Total |
|---|---|---|---|
| United States | 103 | 103 | 206 |
| Europe | 62 | 61 | 123 |
| Israel | 12 | 14 | 26 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2016 to primary completion in May 2019, 36 months.
Results were first posted in Mar 2025, 5 years 10 months after primary completion.
Of 42 industry-sponsored phase 3 interventional studies under Kidney Failure, Chronic, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 40. This study's 36 months is above that.
Counting every sponsor, half of 66 studies reached it within 32 months; a quarter within 21 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hepatitis A virus