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

Study Overview
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Brief Summary
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The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.

Detailed Description
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This study will compare the use of the COVERA™ Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to safety and effectiveness performance goals (PGs) for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV graft.

Official Title
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Prospective, Multi-Center Clinical Study of the Bard® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis at the Graft-Vein Anastomosis of AV Graft Circuits (AVeVA)

Conditions
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Stenosis, Restenosis

Intervention / Treatment
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* Device: Covera(TM) Vascular Covered Stent


Participation Criteria
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Eligibility Criteria
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Clinical Inclusion Criteria: Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures. Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures. Subject must be willing to comply with the protocol requirements, including clinical and telephone follow-up. Subject must have a synthetic AV access graft located in an arm that has been implanted for ≥ 30 days and must have undergone at least one successful dialysis session prior to the index procedure. Angiographic Inclusion Criteria Subject must have angiographic evidence of a stenosis ≥ 50% (by visual estimation) located at the graft-vein anastomosis of the subject's synthetic AV access graft and present with clinical evidence of graft dysfunction at the synthetic AV graft-vein anastomosis. The target lesion must be ≤ 9cm in length. Note: multiple stenoses may exist within the target lesion. The reference vessel diameter of the adjacent non-stenotic vessel must be between 5.0 and 9.0mm. Clinical Exclusion Criteria: The subject is dialyzing with an AV fistula. The hemodialysis access is located in the lower extremity. The subject has an infected AV access graft or uncontrolled systemic infection. The subject has a known uncontrolled blood coagulation/bleeding disorder. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated. The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum. The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up. The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies. Angiographic Exclusion Criteria: Additional stenotic lesions (≥ 50%) in the venous outflow that are > 3cm from the edge of the target lesion and are not successfully treated (defined as < 30% residual stenosis) prior to treating the target lesion. An aneurysm or pseudoaneurysm is present within the target lesion. The location of the target lesion would require the COVERA™ Vascular Covered Stent be deployed across the elbow joint. The target lesion is located within a stent or stent graft. The location of the target lesion would require that the COVERA™ Vascular Covered Stent be placed in the central veins (subclavian, brachiocephalic, Superior Vena Cava (SVC)) or under the clavicle at the thoracic outlet. There is incomplete expansion of an appropriately-sized angioplasty balloon to its expected profile, in the operator's judgment, during primary angioplasty at the target lesion prior to implantation of the study device.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Covera(TM) Vascular Covered Stent<br>Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) | Device: Covera(TM) Vascular Covered Stent<br>* Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events | 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. | 30 days post index procedure | 
| Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency | 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%. | 6 months post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP) | 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. | 1, 3, 6, 12, 18 and 24 months post index procedure | 
| Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP) | 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. | 1, 3, 6, 12, 18 and 24 months post index procedure | 
| Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit | 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. | 1, 3, 6, 12, 18 and 24 months post index procedure, | 
| Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions | 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. | 1, 3, 6, 12, 18 and 24 months post index procedure. | 
| Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions | 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. | 1, 3, 6, 12, 18 and 24 months post index procedure | 
| Endpoint Without Hypothesis Testing: Index of Patency Function (IPF) | 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. | 1, 3, 6, 12, 18 and 24 months post index procedure | 
| Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T) | 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. | 1, 3, 6, 12, 18 and 24 months post index procedure | 
| Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency | 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. | 1, 3, 6, 12, 18 and 24 months post index procedure | 
| Endpoint Without Hypothesis Testing: Number of Participants With Technical Success (for Stent Graft Placement) | 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. | At time of index procedure | 
| Endpoint Without Hypothesis Testing: Number of Participants With Procedure Success | Procedure Success is defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis. | At time of index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, Stenosis, Restenosis, Hemodialysis, AV Graft