Drug Eluting Balloon Venoplasty in AV Fistula Stenosis (NCT02902094) | Clinical Trial Compass
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 range18 Years
SexALL
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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.