CompletedNot Applicable

FLEX Arteriovenous Access Registry

United States114 participantsStarted 2018-05-28

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anatomic Success

Timeframe: At the completion of the index procedure

Trial details

NCT IDNCT04070365

SponsorVentureMed Group Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06-09

View on ClinicalTrials.gov More Peripheral Artery Disease trials