Trial Outcomes & Findings for Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA) (NCT NCT02790606)

Last Updated: 2020-04-14

Results Overview

Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

30 days post index procedure

Results posted on

2020-04-14

Participant Flow

The study was conducted at 14 active sites in the US. Of 181 consented subjects,110 were treated with device and 71 were considered screen failures. No site treated more than 20% of the total number of subjects.The first subject was treated Aug, 3, 2016 and the last one Feb. 27, 2017. The last 24-month follow-up contact occurred Mar. 16, 2019.

Participant milestones

Participant milestones
Measure	Covera(TM) Vascular Covered Stent Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Overall Study STARTED	110
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Covera(TM) Vascular Covered Stent Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Overall Study Death	27
Overall Study Lost to Follow-up	4
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

For three (3) subjects the diameter of the graft at the time of initial access creation on was unknown.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Covera(TM) Vascular Covered Stent n=110 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Age, Customized < 65 years	52 Participants n=110 Participants
Age, Customized ≥ 65 and < 75 years	31 Participants n=110 Participants
Age, Customized ≥ 75 years	27 Participants n=110 Participants
Sex: Female, Male Female	60 Participants n=110 Participants
Sex: Female, Male Male	50 Participants n=110 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=110 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=110 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=110 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=110 Participants
Race (NIH/OMB) Asian	4 Participants n=110 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=110 Participants
Race (NIH/OMB) Black or African American	44 Participants n=110 Participants
Race (NIH/OMB) White	60 Participants n=110 Participants
Race (NIH/OMB) More than one race	0 Participants n=110 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=110 Participants
Region of Enrollment United States	110 Participants n=110 Participants
Hemodialysis - Baseline	19.7 Months on hemodialysis STANDARD_DEVIATION 19.95 • n=110 Participants
AV Access Circuit Description/ Target Limb Left Arm	88 Participants n=110 Participants
AV Access Circuit Description/ Target Limb Right Arm	22 Participants n=110 Participants
AV Access Circuit Description: Graft Location Forearm	2 Participants n=110 Participants
AV Access Circuit Description: Graft Location Upper Arm	108 Participants n=110 Participants
AV Access Circuit Description: Arterial Anastomosis Axillary	14 Participants n=110 Participants
AV Access Circuit Description: Arterial Anastomosis Brachial	94 Participants n=110 Participants
AV Access Circuit Description: Arterial Anastomosis Radial	1 Participants n=110 Participants
AV Access Circuit Description: Arterial Anastomosis Ulnar	1 Participants n=110 Participants
AV Access Circuit Description: Venous Anastomosis Axillary	54 Participants n=110 Participants
AV Access Circuit Description: Venous Anastomosis Basilic	44 Participants n=110 Participants
AV Access Circuit Description: Venous Anastomosis Brachial	9 Participants n=110 Participants
AV Access Circuit Description: Venous Anastomosis Cephalic	2 Participants n=110 Participants
AV Access Circuit Description: Venous Anastomosis Median Cubital	1 Participants n=110 Participants
AV Access Circuit Description: Graft Configuration Loop	33 Participants n=110 Participants
AV Access Circuit Description: Graft Configuration Straight	77 Participants n=110 Participants
AV Access Circuit Description: Graft Material Bovine	10 Participants n=110 Participants
AV Access Circuit Description: Graft Material ePTFE	85 Participants n=110 Participants
AV Access Circuit Description: Graft Material Other	4 Participants n=110 Participants
AV Access Circuit Description: Graft Material Unknown	11 Participants n=110 Participants
AV Access Circuit Description: Graft Tapered Yes	32 Participants n=110 Participants
AV Access Circuit Description: Graft Tapered No	78 Participants n=110 Participants
AV Access Circuit Description: Graft Diameter (mm)	6.6 mm STANDARD_DEVIATION 0.77 • n=107 Participants • For three (3) subjects the diameter of the graft at the time of initial access creation on was unknown.

PRIMARY outcome

Timeframe: 30 days post index procedure

Population: Number of Participants Free from Primary Safety Events (All Treated Subjects)

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=110 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events	106 Participants

PRIMARY outcome

Timeframe: 6 months post index procedure

Population: Number of participants with Target Lesion Primary Patency. In total, nine (9) subjects were excluded from the denominator (110) due to discontinuation or abandonment of their index AV access circuit for non effectiveness reasons prior to Day 150 of their follow-up. Therefore, the Overall Number of Participants analyzed is 101 for this measure.

Target Lesion Primary Patency (TLPP) is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV access graft due to inability to treat the original treatment area. The primary effectiveness endpoint is evaluated against a performance goal (PG) of 40%.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=101 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency	71 Participants

SECONDARY outcome

Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedure

Population: Number of Participants with Target Lesion Primary Patency. Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.

TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV access graft due to inability to treat the original treatment area. The 1, 3, 6, 12, 18 and 24 months final results are reported below.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=109 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP) TLPP at 30-days Follow-Up	100 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP) TLPP at 90-days Follow-up	91 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP) TLPP at 6-month Follow-Up	71 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP) TLPP at 12-month Follow-Up	46 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP) TLPP at 18-month Follow-Up	33 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP) TLPP at 24-month Follow-Up	25 Participants

SECONDARY outcome

Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedure

Population: Number of Participants with Access Circuit Primary Patency (ACPP). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.

ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit. Vessel rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. The 1, 3, 6, 12, 18 and 24 months final results are reported below.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=109 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP) ACPP at 30-days Follow-Up	96 Participants
Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP) ACPP at 90-days Follow-Up	72 Participants
Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP) ACPP at 6-months Follow-Up	40 Participants
Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP) ACPP at 12-months Follow-Up	14 Participants
Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP) ACPP at 18-months Follow-Up	7 Participants
Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP) ACPP at 24-months Follow-Up	4 Participants

SECONDARY outcome

Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedure,

Population: Number of Participants Free from Device/Procedure-Related Adverse Events. Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.

Number of Participants with device and procedure related Adverse Events involving the AV access circuit. The access circuit is the area from the arterial inflow to the SVC-right atrial junction. The 1, 3, 6, 12, 18 and 24 months final results are reported below.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=110 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit 30-days Follow-Up	105 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit 90-days Follow-Up	99 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit 6-months Follow-Up	96 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit 12-months Follow-Up	85 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit 18-months Follow-Up	77 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit 24-months Follow-Up	69 Participants

SECONDARY outcome

Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedure.

Population: Total number of AV Access Circuit Reinterventions by Follow-Up Period. The number for a specific period may be higher than the number of subjects with at least one AV access reintervention in that period. Number of participants (n) varies from overall enrollment (N) due to discontinued participation or not meeting endpoint inclusion criteria.

Total Number of AV Access Circuit Reinterventions defined as the number of reinterventions to the AV access circuit until access abandonment or through study completion. The 1, 3, 6, 12, 18 and 24 months final results are reported below.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=108 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions AV Access Circuit Reinterventions at 30 days	16 AV Access Reinterventions
Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions AV Access Circuit Reinterventions at 90 days	51 AV Access Reinterventions
Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions AV Access Circuit Reinterventions at 6-months	111 AV Access Reinterventions
Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions AV Access Circuit Reinterventions at 12-months	222 AV Access Reinterventions
Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions AV Access Circuit Reinterventions at 18-months	284 AV Access Reinterventions
Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions AV Access Circuit Reinterventions at 24-months	333 AV Access Reinterventions

SECONDARY outcome

Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedure

Population: The (n) in each follow-up periods vary from overall enrollment (N) as some subjects discontinued participation before each follow-up or did not meet endpoint inclusion criteria. The total number of Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Target Lesion Reintervention.

Total Number of Target Lesion Reinterventions defined as the number of reinterventions to maintain target lesion patency. The 1, 3, 6, 12, 18 and 24 months final results are reported below.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=108 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions Target Lesion Reintervention at 24 month Follow-Up	116 Target Lesion Reinterventions
Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions Target Lesion Reintervention at 30 days Follow-Up	10 Target Lesion Reinterventions
Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions Target Lesion Reintervention at 90 days Follow-Up	18 Target Lesion Reinterventions
Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions Target Lesion Reintervention at 6 months Follow-Up	44 Target Lesion Reinterventions
Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions Target Lesion Reintervention at 12 month Follow-Up	81 Target Lesion Reinterventions
Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions Target Lesion Reintervention at 18 month Follow-Up	100 Target Lesion Reinterventions

SECONDARY outcome

Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedure

Population: Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.

IPF is defined as the time from the index study procedure to study completion or access abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis. The 1, 3, 6, 12, 18 and 24 months final results are reported below. The IPF is representative of the number of days between interventions to maintain access circuit patency. The minimum and maximum ranges for the Index of Patency Function are as follows: 1 month (6.3 - 30.0); 3 months (6.3 - 90.0); 6 months (6.3 - 180.0); 12 months (6.3 - 365.0); 18 months (6.3 - 545.0); and 24 months (6.3 - 730.0). Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=108 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Endpoint Without Hypothesis Testing: Index of Patency Function (IPF) Index of Patency Function at 30 days Follow-Up	28.10 Index Standard Deviation 5.446
Endpoint Without Hypothesis Testing: Index of Patency Function (IPF) Index of Patency Function at 90 days Follow-Up	72.24 Index Standard Deviation 26.01
Endpoint Without Hypothesis Testing: Index of Patency Function (IPF) Index of Patency Function at 6 months Follow-Up	110.3 Index Standard Deviation 57.71
Endpoint Without Hypothesis Testing: Index of Patency Function (IPF) Index of Patency Function at 12 months Follow-Up	144.3 Index Standard Deviation 102.6
Endpoint Without Hypothesis Testing: Index of Patency Function (IPF) Index of Patency Function at 18 months Follow-Up	163.1 Index Standard Deviation 131.6
Endpoint Without Hypothesis Testing: Index of Patency Function (IPF) Index of Patency Function at 24 months Follow-Up	177.9 Index Standard Deviation 153.2

SECONDARY outcome

Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedure

IPF-T (Index of Patency Function - Target Lesion) is defined as the time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis. The 1, 3, 6, 12, 18 and 24 months final results are reported below. The IPF for target lesion patency is representative of the approximate (mean) number of days between interventions to maintain target lesion patency. The minimum and maximum ranges for the Index of Patency Function are as follows: 1 month (6.3 - 30.0); 3 months (6.3 - 90.0); 6 months (6.3 - 180.0); 12 months (6.3 - 365.0); 18 months (6.3 - 545.0); and 24 months (6.3 - 730.0). Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=108 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T) IPTF-T at 30 days Follow-Up	28.75 Index Standard Deviation 4.475
Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T) IPTF-T at 90 days Follow-Up	83.27 Index Standard Deviation 18.48
Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T) IPTF-T at 6 months Follow-Up	146.3 Index Standard Deviation 52.30
Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T) IPTF-T at 12 months Follow-Up	253.2 Index Standard Deviation 127.3
Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T) IPTF-T at 18 months Follow-Up	325.7 Index Standard Deviation 197.3
Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T) IPTF-T at 24 months Follow-Up	380.3 Index Standard Deviation 270.7

SECONDARY outcome

Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedure

Population: Post-Intervention Secondary Patency by Follow-Up Period (All Treated Subjects). (n) varies in relation to the number of failures (access abandonment) recorded at 30 days, 90 days and 6 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

Secondary Patency is defined as the interval after the index intervention until the access is abandoned. Multiple repetitive treatments can be included in post-intervention secondary patency. The 1, 3, 6, 12, 18 and 24 months final results are reported below.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=109 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency Participants with Secondary Patency at 30 days	107 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency Participants with Secondary Patency at 90 days	101 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency Participants with Secondary Patency at 6 months	93 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency Participants with Secondary Patency at 12 months	76 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency Participants with Secondary Patency at 18 months	64 Participants
Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency Participants with Secondary Patency at 24 months	53 Participants

SECONDARY outcome

Timeframe: At time of index procedure

Population: Number of Participants with Acute Technical Success (All Treated Subjects)

Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=110 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Endpoint Without Hypothesis Testing: Number of Participants With Technical Success (for Stent Graft Placement)	110 Participants

SECONDARY outcome

Timeframe: At time of index procedure

Population: Procedure Success (All Treated Subjects)

Procedure Success is defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis.

Outcome measures

Outcome measures
Measure	Covera(TM) Vascular Covered Stent n=110 Participants Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Endpoint Without Hypothesis Testing: Number of Participants With Procedure Success	110 Participants

Adverse Events

Covera(TM) Vascular Covered Stent

Serious events: 41 serious events

Other events: 53 other events

Deaths: 27 deaths

Serious adverse events

Serious adverse events
Measure	Covera(TM) Vascular Covered Stent n=110 participants at risk Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
Infections and infestations Arteriovenous Graft Site Infection	6.4% 7/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Vascular Graft Complication	20.0% 22/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Vascular disorders Arteriovenous Fistula	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Vascular disorders Steal Syndrome	2.7% 3/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Vascular disorders Vascular Rupture	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Vascular disorders Vasospasm	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
General disorders Infusion Site Extravasation	3.6% 4/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
General disorders Stent Malfunction	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Infections and infestations Infected Skin Ulcer	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Infections and infestations Wound Infection	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Arteriovenous Graft Aneurysm	3.6% 4/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Arteriovenous Graft Site Haemorrhage	1.8% 2/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Seroma	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Skin Wound	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	4.5% 5/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Vascular disorders Vascular Dissection	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.

Other adverse events

Other adverse events
Measure	Covera(TM) Vascular Covered Stent n=110 participants at risk Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialyzing with an AV graft.
General disorders Local Swelling	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Infections and infestations Arteriovenous Graft Site Infection	6.4% 7/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Arteriovenous Graft Site Haemorrhage	2.7% 3/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Vascular Graft Complication	27.3% 30/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Nervous system disorders Paraesthesia	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Vascular disorders Arteriovenous Fistula	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Vascular disorders Steal Syndrome	4.5% 5/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Vascular disorders Vascular Rupture	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Vascular disorders Vasospasm	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
General disorders Infusion Site Extravasation	3.6% 4/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
General disorders Stent Malfunction	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Infections and infestations Infected Skin Ulcer	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Infections and infestations Wound Infection	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Arteriovenous Graft Aneurysm	3.6% 4/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Arteriovenous Graft Site Haematoma	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Excoriation	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Seroma	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Skin Wound	0.91% 1/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	5.5% 6/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.
Vascular disorders Vascular Dissection	1.8% 2/110 • Adverse events experienced by subjects were collected during a 24-month follow-up period (from the index procedure through the final follow-up contact, or early termination). Adverse events collection was limited to localized or systemic clinical manifestations that reasonably suggests involvement of the AV access circuit (related to graft to the SVC-right atrial junction). Systematic assessment was achieved through scheduled phone calls (or in-office visits) at 30 days, 90 days, 6 months, 12 months, 18 months and 24 months post procedure.

Additional Information

Talar Saber, Clinical Project Manager

C.R. Bard

Phone: 480-379-2839

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Prior to PI publication of site results, sponsor requires publication of multi-centers results.
Publication restrictions are in place

Restriction type: OTHER