Trial Outcomes & Findings for Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis (NCT NCT02644941)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

355 participants

Primary outcome timeframe

12 months post-implantation

Results posted on

2025-03-30

Participant Flow

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

Participant milestones

Participant milestones
Measure	Human Acellular Vessel (HAV) HAV-tissue-engineered vascular conduit (6mm diameter).	ePTFE The comparator is one two commercially available 6 mm ePTFE grafts (Bard Impra® or Gore PROPATEN®)
18 Months STARTED	177	178
18 Months COMPLETED	128	126
18 Months NOT COMPLETED	49	52
24 Months STARTED	177	178
24 Months COMPLETED	108	106
24 Months NOT COMPLETED	69	72
60 Months STARTED	177	178
60 Months COMPLETED	78	80
60 Months NOT COMPLETED	99	98

Reasons for withdrawal

Reasons for withdrawal
Measure	Human Acellular Vessel (HAV) HAV-tissue-engineered vascular conduit (6mm diameter).	ePTFE The comparator is one two commercially available 6 mm ePTFE grafts (Bard Impra® or Gore PROPATEN®)
18 Months Subjects lost graft during the study up to the data cut-off	49	52

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants The comparator is one two commercially available 6 mm ePTFE grafts (Bard Impra® or Gore PROPATEN®)	Total n=355 Participants Total of all reporting groups
Age, Customized 18-21 years	0 Age range of participants n=93 Participants	1 Age range of participants n=4 Participants	1 Age range of participants n=27 Participants
Age, Customized 22-44 years	21 Age range of participants n=93 Participants	22 Age range of participants n=4 Participants	43 Age range of participants n=27 Participants
Age, Customized 45-64 years	69 Age range of participants n=93 Participants	78 Age range of participants n=4 Participants	147 Age range of participants n=27 Participants
Age, Customized 65-74 years	57 Age range of participants n=93 Participants	50 Age range of participants n=4 Participants	107 Age range of participants n=27 Participants
Age, Customized >/= 75 years	30 Age range of participants n=93 Participants	27 Age range of participants n=4 Participants	57 Age range of participants n=27 Participants
Sex: Female, Male Female	89 Participants n=93 Participants	90 Participants n=4 Participants	179 Participants n=27 Participants
Sex: Female, Male Male	88 Participants n=93 Participants	88 Participants n=4 Participants	176 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=93 Participants	20 Participants n=4 Participants	46 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	129 Participants n=93 Participants	127 Participants n=4 Participants	256 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	22 Participants n=93 Participants	31 Participants n=4 Participants	53 Participants n=27 Participants
Race/Ethnicity, Customized White	123 Participants n=93 Participants	116 Participants n=4 Participants	239 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	44 Participants n=93 Participants	49 Participants n=4 Participants	93 Participants n=27 Participants
Race/Ethnicity, Customized Asian	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Region of Enrollment United States	103 participants n=93 Participants	103 participants n=4 Participants	206 participants n=27 Participants
Region of Enrollment Europe	62 participants n=93 Participants	61 participants n=4 Participants	123 participants n=27 Participants
Region of Enrollment Israel	12 participants n=93 Participants	14 participants n=4 Participants	26 participants n=27 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Number of Participants With Loss of Secondary Patency	29 Participants	34 Participants

PRIMARY outcome

Timeframe: 18 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).

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Number of Participants With Loss of Secondary Patency	41 Participants	37 Participants

PRIMARY outcome

Timeframe: 24 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).

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Number of Participants With Loss of Secondary Patency	48 Participants	41 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Number of Participants With Loss of Primary Patency	118 Participants	78 Participants

SECONDARY outcome

Timeframe: 18 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.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Number of Participants With Loss of Primary Patency	146 Participants	111 Participants

SECONDARY outcome

Timeframe: 24 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.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Number of Participants With Loss of Primary Patency	132 Participants	104 Participants

SECONDARY outcome

Timeframe: 60 months post-implantation

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.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Number of Participants With Loss of Primary Patency	146 Participants	121 Participants

SECONDARY outcome

Timeframe: 24 months post-implantation

No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Study Conduit Abandonment	57 Participants	44 Participants

SECONDARY outcome

Timeframe: 60 months post-implantation

No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Study Conduit Abandonment	69 Participants	53 Participants

SECONDARY outcome

Timeframe: 24 months post-implantation

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

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Rate of Adjudicated Study Conduit Access Related Infections	0.93 Events per 100 Person-Years	4.54 Events per 100 Person-Years

SECONDARY outcome

Timeframe: 60 months post-implantation

Using Dialysis Event Surveillance Manual: CDC; 2013.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Access-related Infections	17 Access related infection events	27 Access related infection events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Participants With at Least 1 Intervention Required to Achieve/Maintain Secondary Patency	146 Participants	116 Participants

SECONDARY outcome

Timeframe: 60 months post-implantation

Population: Non-oversized ballon use (no greater than 6 mm)

Total number of interventions performed by treatment group stratified by any use of balloon size no \> 6 millimeters.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 6 Millimeters)	2.7 Interventions per participant Standard Deviation 3.68	2.7 Interventions per participant Standard Deviation 3.77

SECONDARY outcome

Timeframe: 60 months post-implantation

Population: Oversized ballon use (greater than 6 mm)

Total number of interventions performed by treatment group stratified by any use of balloon size greater than 6 millimeters.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 6 Millimeters)	7.3 Interventions per participant Standard Deviation 5.74	2.7 Interventions per participant Standard Deviation 3.77

SECONDARY outcome

Timeframe: 24 months post-implantation

Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Thrombosis of Study Access That Required Intervention	361 Thrombosis events requiring intervention	170 Thrombosis events requiring intervention

SECONDARY outcome

Timeframe: 60 months post-implantation

Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Thrombosis of Study Access That Required Intervention	409 Thrombosis events requiring intervention	205 Thrombosis events requiring intervention

SECONDARY outcome

Timeframe: 2 to 18 Months post-implantation

Population: Female and Male

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.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=69 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=72 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects)	1.61 unitless Standard Deviation 0.551	1.67 unitless Standard Deviation 0.445

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Severity of Adverse Events Mild	8 Participants	9 Participants
Severity of Adverse Events Moderate	39 Participants	55 Participants
Severity of Adverse Events Severe	74 Participants	64 Participants
Severity of Adverse Events Life-threatening	9 Participants	7 Participants
Severity of Adverse Events Death	45 Participants	39 Participants

SECONDARY outcome

Timeframe: 24 months post-implantation

Collection of all Adverse Events beginning on Day 0 after implantation up to 2 years post implantation (Month 24).

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Number of Participants With at Least One Adverse Event	175 Participants	174 Participants

SECONDARY outcome

Timeframe: 24 months post-implantation

Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)	19 Total number of aneurysms	11 Total number of aneurysms

SECONDARY outcome

Timeframe: 60 months post-implantation

Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)	23 Total number of aneurysms	12 Total number of aneurysms

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Pseudoaneurysm Formation	98 Pseudoaneurysms	47 Pseudoaneurysms

SECONDARY outcome

Timeframe: 60 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.

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Pseudoaneurysm Formation	113 Pseudoaneurysms	59 Pseudoaneurysms

SECONDARY outcome

Timeframe: 24 months post-implantation

Assessed by ultrasound

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury	0 Ruptures d/t iatrogenic injury	0 Ruptures d/t iatrogenic injury

SECONDARY outcome

Timeframe: 60 months post-implantation

Assessed by ultrasound

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury	0 Ruptures d/t iatrogenic injury	0 Ruptures d/t iatrogenic injury

SECONDARY outcome

Timeframe: 24 months post-implantation

Assessed by ultrasound

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Anastomotic Bleeding or Rupture	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 months post-implantation

Assessed by ultrasound

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Anastomotic Bleeding or Rupture	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 18 months post-implantation

Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Calculated Panel Reactive Antibody More Than 20% Change From Baseline	3 Participants	8 Participants

SECONDARY outcome

Timeframe: 24 months post-implantation

Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Calculated Panel Reactive Antibody More Than 20% Change From Baseline	2 Participants	10 Participants

SECONDARY outcome

Timeframe: 12 months post-implantation

Duplex ultrasonography: diameter of the mid-conduit lumen

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Mean Inner Diameter of Conduit (Millimeter)	6.20 Inner diameter (millimeter) Standard Deviation 1.452	5.66 Inner diameter (millimeter) Standard Deviation 1.601

SECONDARY outcome

Timeframe: 24 months post-implantation

Duplex ultrasonography: diameter of the mid-conduit lumen

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Mean Inner Diameter of Conduit (Millimeter)	6.02 Inner diameter (millimeter) Standard Deviation 2.898	5.88 Inner diameter (millimeter) Standard Deviation 2.209

SECONDARY outcome

Timeframe: 60 months post-implantation

Duplex ultrasonography: diameter of the mid-conduit lumen

Outcome measures

Outcome measures
Measure	Human Acellular Vessel (HAV) n=177 Participants HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 Participants One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Mean Inner Diameter of Conduit (Millimeter)	6.19 Inner diameter (millimeter) Standard Deviation 1.979	6.23 Inner diameter (millimeter) Standard Deviation 1.131

Adverse Events

Human Acellular Vessel (HAV)

Serious events: 157 serious events

Other events: 176 other events

Deaths: 46 deaths

ePTFE

Serious events: 146 serious events

Other events: 176 other events

Deaths: 39 deaths

Serious adverse events

Serious adverse events
Measure	Human Acellular Vessel (HAV) n=177 participants at risk HAV-tissue-engineered vascular conduit (6mm diameter)	ePTFE n=178 participants at risk One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Blood and lymphatic system disorders Anemia	4.0% 7/177 • Number of events 9 • 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.	5.6% 10/178 • Number of events 13 • 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.
Cardiac disorders Cardiac arrest	3.4% 6/177 • Number of events 38 • 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.	6.2% 11/178 • Number of events 32 • 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.
Cardiac disorders Cardiac failure congestive	3.4% 6/177 • Number of events 38 • 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.	4.5% 8/178 • Number of events 32 • 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.
Infections and infestations Pneumonia	6.2% 11/177 • Number of events 61 • 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.	10.1% 18/178 • Number of events 72 • 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.
Infections and infestations Sepsis	7.3% 13/177 • Number of events 61 • 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.	6.7% 12/178 • Number of events 72 • 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.
Infections and infestations Vascular access site infection	7.3% 13/177 • Number of events 61 • 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.	10.1% 18/178 • Number of events 72 • 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.
Injury, poisoning and procedural complications Vascular access site pseudoaneurysm	9.6% 17/177 • Number of events 99 • 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.	2.8% 5/178 • Number of events 71 • 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.
Injury, poisoning and procedural complications Vascular access site thrombosis	45.8% 81/177 • Number of events 99 • 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.	32.0% 57/178 • Number of events 71 • 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.
Metabolism and nutrition disorders Hyperkalemia	5.1% 9/177 • Number of events 21 • 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.	5.1% 9/178 • Number of events 26 • 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.
Vascular disorders Hypotension	5.6% 10/177 • Number of events 77 • 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.	2.2% 4/178 • Number of events 69 • 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.
Vascular disorders Vascular stenosis	29.9% 53/177 • Number of events 77 • 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.	27.5% 49/178 • Number of events 69 • 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.
Vascular disorders Venous stenosis	4.0% 7/177 • Number of events 78 • 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.	5.1% 9/178 • Number of events 74 • 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.

Other adverse events

Additional Information

Shamik Parikh, Chief Medical Officer

Humacyte Global Inc

Phone: 919-313-9633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place