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

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.
• •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.