UnknownNot Applicable

Drug Eluting Balloon Venoplasty in AV Fistula Stenosis

United Kingdom186 participantsStarted 2016-01

Plain-language summary

DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula 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: * Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis. * Fistula has been in use for at least 1 month and is \> 6 weeks old * Brachiocephalic AV fistula * Brachiobasilic AV fistula * Radiocephalic AV fistula (both proximal and distal) * Participant \>/=18 yrs old * Index lesion is less then the length of the DEB, and the reference vessel diameter is appropriate for treatment with the size range of DEB (4mm - 8mm diameter) * Participant is able to give valid informed consent Exclusion Criteria: * Allergy to iodinated Intravenous contrast * Allergy to Paclitaxel * Prosthetic grafts * Long or tandem lesions that cannot be treated with a single DEB * Thrombosed Arterio-Venous fistulas * Women who are breastfeeding, pregnant or intending to become pregnant * Participants of child-bearing age who are unwilling to use a reliable form of contraception for the duration of the study.

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

Patency

Timeframe: 12 months

Trial details

NCT IDNCT02902094

SponsorUniversity Hospital Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

Contact for this trial

N E Anderson

+441216272000

View on ClinicalTrials.gov More Native Arteriovenous Fistula trials

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.