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

TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at, or adjacent to,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 fistula due to inability to treat the original treatment area. COVERA Vascular Covered Stent (following PTA) is evaluated against subjects treated PTA alone.

Time frame: 6 months post index procedure

Population: Number of Participants with Target Lesion Primary Patency. Modified Intended to Treat (mITT) population results were analyzed for this effectiveness endpoint. N = number of subjects in mITT population with evaluable data. Excluded subjects that discontinued, expired and or access abandoned prior to day 15.

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 Intended to Treat Subjects (ITT) are included in this analysis. Primary safety endpoint evaluated against standard PTA alone.2 subjects excluded from N COVERA due to discontinuation or death prior to day 23 of follow up. One subject excluded from N PTA arm due to death prior to follow up.

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. A visit is defined as one (1) procedural event, regardless of the number or type of interventions performed during the visit. The index procedure is counted as the first visit to ensure all subjects have a denominator of at least one. Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months. The IPF is representative of the number of days between interventions to maintain access circuit patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions. mITT results are analyzed.

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.~mITT subjects results are presented.

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. Whereas the measure time frames for the overall study are 1, 3, 6, 12, 18 and 24 months. The IPF for target lesion patency is representative of the approximate (mean) number of days between interventions to maintain target lesion patency. 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.~mITT subjects results are presented.

Number of Participants Free from Device and Procedure Related AEs Involving the AV Access Circuit (ITT population). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria. The relationships with device/procedure of the events are based on CEC adjudications.

Time frame: Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure

Population: Number of Participants Free from Device and Procedure (DP) Related AEs Involving the AV Access Circuit (ITT subjects).~Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days 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. N = number of subjects in the mITT Population with evaluable data.

Time frame: 1, 3, 12, 18, and 24 months post index procedure

Population: Number of Participants with ACPP by Follow-up Period (mITT subjects). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days and 90 days 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. Testing of this secondary endpoint is performed in a hierarchical fashion. Thus, In order to perform hypothesis test of ACPP at 6-month, TLPP at 12-months must be successful.

Time frame: 6 months post index procedure

Population: Number of Participants with Access Circuit Primary Patency (ACPP). Modified Intended to Treat (mITT) population results were analyzed for this effectiveness endpoint. N = number of subjects in mITT population with evaluable data. Excluded subjects that discontinued, expired and or access abandoned prior to day 15.

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. Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study. mITT subjects results are presented.

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

Population: Post-Intervention Secondary Patency by Follow-Up Period (mITT 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. Procedure success was assessed on the day the index procedure was performed, which may be a different day for each participant.

Time frame: On Day of Index Procedure

Population: Procedure Success (mITT Subjects). Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.

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. mITT subjects results are presented. N= number of subjects in the mITT Population with evaluable data. Evaluation through 1, 3, 18 and 24 months post index procedure.

Time frame: 1, 3, 18 and 24 months post index procedure

Population: Number of Participants with Target Lesion Primary Patency (TLPP). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days or 90 days 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. Therefore, for this measure, only COVERA data are relevant. mITT results are presented. Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria. Technical success was assessed on the day the index procedure was performed, which may be a different day for each participant.

Time frame: On Day of Index Procedure

Population: Number of Participants with Acute Technical Success (mITT Subjects). Please note that 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. Therefore, for this measure, only COVERA data are relevant.

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 fistula due to inability to treat the original treatment area.

Time frame: 12 months post-index procedure

Population: Number of Participants with Target Lesion Primary Patency (TLPP). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 12 month follow-up or did not meet endpoint inclusion criteria.

Defined as the number of reinterventions to the AV access circuit until access abandonment or through study completion. Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study. MITT results are presented for this analysis.

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 Access Circuit Reintervention -mITT subjects

Total Number of Target Lesion Reinterventions defined as the number of reinterventions to maintain target lesion patency (mITT subjects). Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months.

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 Target Lesion Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Target Lesion Reintervention.