Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA)

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%.

Time frame: 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.

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.

Time frame: 30 days post index procedure

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

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.

Time frame: 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.

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.

Time frame: 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-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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.

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

Time frame: At time of index procedure

Population: Procedure Success (All Treated Subjects)

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.

Time frame: 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.

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.

Time frame: At time of index procedure

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

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.

Time frame: 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 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.

Time frame: 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.