NCT02902094UnknownNot Applicable
Improving Outcomes in Fistula Intervention: A Prospective, Patient Blinded, Phase 3, Randomised Controlled Trial of Drug Eluting Balloons in the Angioplasty of Native Haemodialysis Access Arteriovenous Fistula Outflow Stenosis (DeVA)
University Hospital Birmingham2 sites in 1 country186 target enrollmentStarted: January 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 186
- Locations
- 2
- Primary Endpoint
- Patency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Patency
Time Frame: 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 Outcomes
- Technical success(Time of baseline index intervention)
- Assisted technical success of balloon angioplasty(At time of baseline index intervention)
- Successful use of fistula for dialysis(In the 12 months following baseline index intervention)
- Secondary patency of the access circuit(In the 12 months following baseline index intervention)
Investigators
Study Sites (2)
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