Native Arteriovenous Fistula, Stenosis
Conditions
Brief 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.
Interventions
DEVICEDrug eluting balloons
DEVICENon drug eluting balloons
Sponsors
Boston Scientific Corporation
University Hospital Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency | 12 months | Primary end point is a composite of one or more of : * \>50% stenosis of index lesion requiring re-intervention * Re-intervention of index lesion due to clinical indications without 50% re-stenosis * Fistula failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Time of baseline index intervention | Defined as \<30% residual stenosis using only the study balloon to which the patient was randomised |
| Assisted technical success of balloon angioplasty | At time of baseline index intervention | Defined as \<30% residual stenosis using adjunctive procedures in addition to study balloon |
| Successful use of fistula for dialysis | In the 12 months following baseline index intervention | Defined as successful use of the fistula for dialysis using 2 needles on at least one occasion |
| Secondary patency of the access circuit | In the 12 months following baseline index intervention | — |
Countries
United Kingdom
Contacts
Primary ContactN E Anderson
Outcome results
None listed