Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Subject is ≥18 years of age.
  • Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:
    • Elevated venous pressure during hemodialysis,
    • Abnormal physical findings, and
    • Unexplained decrease in delivered dialysis dose.
  • Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.
  • Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.
  • Subject understands the study and is willing and able to comply with the follow-up requirements.

• Key Exclusion Criteria

  A patient will not be eligible for participation in this study if any of the following criteria apply.

  • Subject has a known or suspected systemic infection.
  • Subject has a known or suspected infection of the hemodialysis graft.
  • Subject has an untreatable allergy to radiographic contrast material.
  • In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.