The Pristine Post-Market Study

Exclusion Criteria

• •1. The participant has known central venous stenosis
• •2. Based on the local primary investigator's discretion, the patient would not be an appropriate study candidate.
• •3. The participant has already undergone an AVF or AVG procedure and is awaiting maturation.
• •4. The participant has an active infection at the time of study enrollment.
• •5. The participant has a presence of bacteremia or infection within 7 days prior to enrollment.
• •6. The participant has a history neutropenia or a history of severe immunodeficiency disease.
• •7. The participant has uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding at time of enrollment per physicians opinion.
• •8. The participant has a known allergy, intolerance or sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
• •9. The participant has a known allergy or hypersensitivity to any of the device materials or Ethylene oxide (EtO).
• •10. The participant has another medical condition or treatment, which in the opinion of the investigator, the participant may be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for completion of study procedures and follow-up.
• •11. The participant 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.