CompletedNCT02644941Updated Aug 19, 2026Results posted

Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis

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

Phase: Phase 3
Study type: Interventional
Enrollment: 355
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.

Read the 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.

Conditions studied

Renal Failure
End Stage Renal Disease
Hemodialysis
Vascular Access

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 355 participants (actual)

Study arms

Experimental
Human Acellular Vessel (HAV)
HAV-tissue-engineered vascular conduit (6mm diameter)
Biological: Human Acellular Vessel (HAV)
Active comparator
ePTFE
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Device: ePTFE graft

Interventions

BiologicalHuman Acellular Vessel (HAV)
HAV-tissue-engineered vascular conduit (6mm diameter)
Also known as: (regulated as a biological product)
DeviceePTFE graft
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Results

Posted Mar 30, 2025

Participant flow

This was a large multicenter comparative study conducted at 37 centers in 6 countries to compare the HAV and ePTFE.

18 months

Participant flow — 18 months
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

24 months

Participant flow — 24 months
Milestone	Human Acellular Vessel (HAV)	ePTFE
Started	177	178
Completed	108	106
Not completed	69	72

60 months

Participant flow — 60 months
Milestone	Human Acellular Vessel (HAV)	ePTFE
Started	177	178
Completed	78	80
Not completed	99	98

Outcome measures

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Loss of Secondary Patency
Participants	Human Acellular Vessel (HAV)	ePTFE
Number of Participants With Loss of Secondary Patency	29	34

PrimaryNumber of Participants With Loss of Secondary Patency

Time frame:: 18 months post-implantation
Reported as:: Count of participants · Participants

Number of Participants With Loss of Secondary Patency
Participants	Human Acellular Vessel (HAV)	ePTFE
Number of Participants With Loss of Secondary Patency	41	37

PrimaryNumber of Participants With Loss of Secondary Patency

Time frame:: 24 months post-implantation
Reported as:: Count of participants · Participants

Number of Participants With Loss of Secondary Patency
Participants	Human Acellular Vessel (HAV)	ePTFE
Number of Participants With Loss of Secondary Patency	48	41

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Loss of Primary Patency
Participants	Human Acellular Vessel (HAV)	ePTFE
Number of Participants With Loss of Primary Patency	118	78

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Loss of Primary Patency
Participants	Human Acellular Vessel (HAV)	ePTFE
Number of Participants With Loss of Primary Patency	146	111

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Loss of Primary Patency
Participants	Human Acellular Vessel (HAV)	ePTFE
Number of Participants With Loss of Primary Patency	132	104

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Loss of Primary Patency
Participants	Human Acellular Vessel (HAV)	ePTFE
Number of Participants With Loss of Primary Patency	146	121

SecondaryStudy 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
Reported as:: Count of participants · Participants

Study Conduit Abandonment
Participants	Human Acellular Vessel (HAV)	ePTFE
Study Conduit Abandonment	57	44

SecondaryStudy 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
Reported as:: Count of participants · Participants

Study Conduit Abandonment
Participants	Human Acellular Vessel (HAV)	ePTFE
Study Conduit Abandonment	69	53

SecondaryRate of Adjudicated Study Conduit Access Related Infections

Adjudicated using the standard definition of access-related infections (CDC; 2013).

Time frame:: 24 months post-implantation
Reported as:: Number · Events per 100 Person-Years

Rate of Adjudicated Study Conduit Access Related Infections
Events per 100 Person-Years	Human Acellular Vessel (HAV)	ePTFE
Rate of Adjudicated Study Conduit Access Related Infections	0.93	4.54

SecondaryAccess-related Infections

Using Dialysis Event Surveillance Manual: CDC; 2013.

Time frame:: 60 months post-implantation
Reported as:: Number · Access related infection events

Access-related Infections
Access related infection events	Human Acellular Vessel (HAV)	ePTFE
Access-related Infections	17	27

SecondaryParticipants 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
Reported as:: Count of participants · Participants

Participants With at Least 1 Intervention Required 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

SecondaryTotal 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
Reported as:: Mean · Interventions per participant

Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 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

SecondaryTotal 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
Reported as:: Mean · Interventions per participant

Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 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

SecondaryThrombosis 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
Reported as:: Number · Thrombosis events requiring intervention

Thrombosis of Study Access That Required Intervention
Thrombosis events requiring intervention	Human Acellular Vessel (HAV)	ePTFE
Thrombosis of Study Access That Required Intervention	361	170

SecondaryThrombosis 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
Reported as:: Number · Thrombosis events requiring intervention

Thrombosis of Study Access That Required Intervention
Thrombosis events requiring intervention	Human Acellular Vessel (HAV)	ePTFE
Thrombosis of Study Access That Required Intervention	409	205

SecondaryDialysis 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
Reported as:: Mean · unitless

Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects)
unitless	Human Acellular Vessel (HAV)	ePTFE
Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects)	1.61 ± 0.551	1.67 ± 0.445

SecondarySeverity 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
Reported as:: Count of participants · Participants

Severity of Adverse Events
Participants	Human Acellular Vessel (HAV)	ePTFE
Mild	8	9
Moderate	39	55
Severe	74	64
Life-threatening	9	7
Death	45	39

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With at Least One Adverse Event
Participants	Human Acellular Vessel (HAV)	ePTFE
Number of Participants With at Least One Adverse Event	175	174

SecondaryTrue 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
Reported as:: Number · Total number of aneurysms

True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)
Total number of aneurysms	Human Acellular Vessel (HAV)	ePTFE
True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)	19	11

SecondaryTrue 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
Reported as:: Number · Total number of aneurysms

True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)
Total number of aneurysms	Human Acellular Vessel (HAV)	ePTFE
True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)	23	12

SecondaryPseudoaneurysm 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
Reported as:: Number · Pseudoaneurysms

Pseudoaneurysm Formation
Pseudoaneurysms	Human Acellular Vessel (HAV)	ePTFE
Pseudoaneurysm Formation	98	47

SecondaryPseudoaneurysm 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
Reported as:: Number · Pseudoaneurysms

Pseudoaneurysm Formation
Pseudoaneurysms	Human Acellular Vessel (HAV)	ePTFE
Pseudoaneurysm Formation	113	59

SecondaryStudy Conduit Spontaneous Ruptures Due to Iatrogenic Injury

Assessed by ultrasound

Time frame:: 24 months post-implantation
Reported as:: Number · Ruptures d/t iatrogenic injury

Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury
Ruptures d/t iatrogenic injury	Human Acellular Vessel (HAV)	ePTFE
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury	0	0

SecondaryStudy Conduit Spontaneous Ruptures Due to Iatrogenic Injury

Assessed by ultrasound

Time frame:: 60 months post-implantation
Reported as:: Number · Ruptures d/t iatrogenic injury

Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury
Ruptures d/t iatrogenic injury	Human Acellular Vessel (HAV)	ePTFE
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury	0	0

SecondaryAnastomotic Bleeding or Rupture

Assessed by ultrasound

Time frame:: 24 months post-implantation
Reported as:: Count of participants · Participants

Anastomotic Bleeding or Rupture
Participants	Human Acellular Vessel (HAV)	ePTFE
Anastomotic Bleeding or Rupture	0	0

SecondaryAnastomotic Bleeding or Rupture

Assessed by ultrasound

Time frame:: 60 months post-implantation
Reported as:: Count of participants · Participants

Anastomotic Bleeding or Rupture
Participants	Human Acellular Vessel (HAV)	ePTFE
Anastomotic Bleeding or Rupture	0	0

SecondaryCalculated 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
Reported as:: Count of participants · Participants

Calculated Panel Reactive Antibody More Than 20% Change From Baseline
Participants	Human Acellular Vessel (HAV)	ePTFE
Calculated Panel Reactive Antibody More Than 20% Change From Baseline	3	8

SecondaryCalculated 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
Reported as:: Count of participants · Participants

Calculated Panel Reactive Antibody More Than 20% Change From Baseline
Participants	Human Acellular Vessel (HAV)	ePTFE
Calculated Panel Reactive Antibody More Than 20% Change From Baseline	2	10

SecondaryMean Inner Diameter of Conduit (Millimeter)

Duplex ultrasonography: diameter of the mid-conduit lumen

Time frame:: 12 months post-implantation
Reported as:: Mean · Inner diameter (millimeter)

Mean Inner Diameter of Conduit (Millimeter)
Inner diameter (millimeter)	Human Acellular Vessel (HAV)	ePTFE
Mean Inner Diameter of Conduit (Millimeter)	6.20 ± 1.452	5.66 ± 1.601

SecondaryMean Inner Diameter of Conduit (Millimeter)

Duplex ultrasonography: diameter of the mid-conduit lumen

Time frame:: 24 months post-implantation
Reported as:: Mean · Inner diameter (millimeter)

Mean Inner Diameter of Conduit (Millimeter)
Inner diameter (millimeter)	Human Acellular Vessel (HAV)	ePTFE
Mean Inner Diameter of Conduit (Millimeter)	6.02 ± 2.898	5.88 ± 2.209

SecondaryMean Inner Diameter of Conduit (Millimeter)

Duplex ultrasonography: diameter of the mid-conduit lumen

Time frame:: 60 months post-implantation
Reported as:: Mean · Inner diameter (millimeter)

Mean Inner Diameter of Conduit (Millimeter)
Inner diameter (millimeter)	Human Acellular Vessel (HAV)	ePTFE
Mean Inner Diameter of Conduit (Millimeter)	6.19 ± 1.979	6.23 ± 1.131

Other pre-specifiedKaplan-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
Reported as:: Number · Percentage of Participants

Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup
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)

Other pre-specifiedKaplan-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
Reported as:: Number · Percentage of Participants

Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup
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)

Other pre-specifiedKaplan-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
Reported as:: Number · Percentage of Participants

Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup
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)

Other pre-specifiedKaplan-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
Reported as:: Number · Percentage of Participants

Kaplan-Meier Estimate of Secondary Patency in the Female Subgroup
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)

Adverse events

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.

Adverse event summary by group
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%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
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

Most frequent other events

Showing 10 of 32

Most frequent other events
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

Baseline characteristics

Age, Customized
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
Sex: Female, Male(Participants)	Human Acellular Vessel (HAV)	ePTFE	Total
Female	89	90	179
Male	88	88	176

Ethnicity (NIH/OMB)
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
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
Region of Enrollment(participants)	Human Acellular Vessel (HAV)	ePTFE	Total
United States	103	103	206
Europe	62	61	123
Israel	12	14	26

Study locations

38 sites

Arizona Kidney Disease and Hypertension Center (AKDHC)
Phoenix, Arizona 85012, United States
Carondelet St. Mary's Hospital
Tucson, Arizona 85745, United States
Ladenheim Dialysis Access Center
Fresno, California 93710, United States
General Surgery and Vascular Access
Fresno, California 93720, United States
University of California Irvine (UCI) Medical Center
Irvine, California 92868, United States
VA Long Beach Healthcare System
Long Beach, California 90822, United States
VA Sacramento Medical Center
Mather, California 95655, United States
Balboa Nephrology
San Diego, California 92123, United States
University of South Florida
Tampa, Florida 33606, United States
Southwest Vascular Access Center
Alsip, Illinois 60803, United States
University of Maryland Medical Center
Baltimore, Maryland 21201, United States
Brigham and Women's Hospital
Boston, Massachusetts 02115, United States
Michigan Cardiovascular Institute
Flint, Michigan 48507, United States
Greenwood Leflore Hospital
Greenwood, Mississippi 38930, United States
Washington University School of Medicine
St Louis, Missouri 63110, United States
Rutgers-New Jersey Medical School
Newark, New Jersey 07103, United States
The Cardiovascular Care Group
Westfield, New Jersey 07090, United States
Duke University Hospital
Durham, North Carolina 27705, United States
Kaiser Permanente
Portland, Oregon 97201, United States
Medical University of South Carolina (MUSC)
Orangeburg, South Carolina 29118, United States
Baylor Scott and White Research Institute
Dallas, Texas 75226, United States
University of Wisconsin
Madison, Wisconsin 53706, United States
Universitätsklinikmn Erlangen, Gefäßchirurgie - Chirurgisches Zentrum
Erlangen, Bavaria 91054, Germany
Universitätsklinikum Frankfurt Klinik für Gefäß- und Endovascular-Chirurgie
Frankfurt am Main, Hesse 60590, Germany
Rambam Health Care Campus
Haifa, Haifa District 3109601, Israel
The Chaim Sheba Medical Center
Ramat Gan, Tel Aviv 52621, Israel
Hillel Jaffe Medical Center
Hadera, 38100, Israel
Sharee Zedek Medical Center
Jerusalem, 9103102, Israel
Yitzhak Shamir Medical Center - Assaf Harofeh
Tzrifin, 70300, Israel
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, 61-848, Poland
Samodzielny Publiczyn Centralny Szpital Klinziczny w Warszawie - Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, 02-097, Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu
Wroclaw, 51-124, Poland
Grupo de Estudos Vasculares
Porto, 4050-190, Portugal
Leicester General Hospital
Leicester, East Midlands/ Leicestershire LE5 4PW, United Kingdom
Guy´s Hospital, Kings´College London
London, Greater London SE1 9RT, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands B15 2TH, United Kingdom
Queen Elizabeth University Hospital Glasgow
Glasgow, G51 4TF, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom

References and documents

Publications

Wang J, Blalock SKF, Levitan GS, Prichard HL, Niklason LE, Kirkton RD. Biological mechanisms of infection resistance in tissue engineered blood vessels compared to synthetic expanded polytetrafluoroethylene grafts. JVS Vasc Sci. 2023 Jul 14;4:100120. doi: 10.1016/j.jvssci.2023.100120. eCollection 2023. PubMed 37662589 ↗

Study documents

Study protocol · Aug 8, 2018
Statistical analysis plan · Sep 22, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT02644941
Lead sponsor: Humacyte, Inc.
Collaborators: CTI Clinical Trial and Consulting Services, California Institute for Regenerative Medicine (CIRM)
Responsible party: Sponsor
First posted: Jan 1, 2016
Start date: May 24, 2016
Primary completion: May 2019
Completion: Sep 2023
Results posted: Mar 30, 2025
Last update: Aug 19, 2026

Study contacts

Shamik Parikh, MD

study director · Humacyte, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis

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