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

Exclusion Criteria

• •1. The subject is dialyzing with an AV graft.
• •2. The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure.
• •3. The hemodialysis access is located in the lower extremity.
• •4. The subject has an infected AV fistula or uncontrolled systemic infection.
• •5. The subject has a known uncontrolled blood coagulation/bleeding disorder.
• •6. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
• •7. The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.
• •8. 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.
• •9. 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.
• •10. 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.
• •11. An aneurysm or pseudoaneurysm is present within the target lesion.
• •12. The location of the target lesion would require the COVERATM Vascular Covered Stent be deployed across the elbow joint.
• •13. The target lesion is located within a stent.
• •14. The location of the target lesion would require that the COVERA™ Vascular Covered Stent be deployed at or across the segment of fistula utilized for dialysis needle puncture (i.e., "cannulation zone").
• •15. 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.
• •16. 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.