FLEX Arteriovenous Access Registry

Completed

Conditions studied: Peripheral Artery Disease, Arteriovenous Fistula Stenosis, Arteriovenous Graft Stenosis

In brief

Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.

Key facts

Study ID

NCT04070365

Run by

VentureMed Group Inc.

People needed

114

Starts

2018-05-28

Expected to finish

2022-05-26

Last updated by the study team

2022-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities.
• The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form.
• The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
• The patient understands the study and is willing and able to comply with follow-up requirements.
• The patient is willing to provide informed consent.

You may not qualify if…

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

Where it is running

• Grandview Medical Center — Birmingham, Alabama, United States
• Flowers Hospital — Dothan, Alabama, United States
• University of Alabama — Tuscaloosa, Alabama, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• SSM Health SLU — St Louis, Missouri, United States
• FirstHealth Moore Regional Hospital — Pinehurst, North Carolina, United States
• JOBST Vascular Institute — Toledo, Ohio, United States
• Dialysis Access Institute — Orangeburg, South Carolina, United States
• Richmond Vascular — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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