CompletedNot Applicable

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)

Australia, New Zealand12 participantsStarted 2018-12-05

Plain-language summary

The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.

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

. Subjects must be ≥18 years of age.
. Native AV fistula has been created ≥60 days prior to the index procedure.
. AV fistula, located in the arm, has undergone one or more successful hemodialysis sessions.
. Target de novo or non-stented restenotic lesion consisting of a ≥50% stenosis by operator visual estimate.
. Fistula vessel diameter ≥5 mm and ≤7 mm by operator visual estimate.
. Target lesion or tandem lesion ≤120 mm in total length by operator visual estimate.
. Successful pre-dilatation of the target lesion. Defined as crossing of the guide wire AND pre-dilatation with a PTA balloon resulting in: residual stenosis of ≤30% and dissection ≤ Grade B
. Subject has provided written informed consent and is willing to comply with study follow-up requirements.

Exclusion criteria

. Subject has a synthetic AV graft.
. Determined by operator to have a lesion that prevents complete inflation of an angioplasty balloon.

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

Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure

Timeframe: 6 months

Trial details

NCT IDNCT03734679

SponsorSurModics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-19

Results submitted2022-08-11

View on ClinicalTrials.gov More Hemodialysis Access Failure trials