FLEX FIRST Registry Research Protocol (VMG-2022-001)

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.

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.

To learn more, visit ClinicalTrials.Gov

Study Type

Registry

Principal Investigator(s)

Ari Kramer, MD

Sponsor(s)

VenturMed Group, Inc.