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

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.