ISRCTN14567609
Completed
Phase 3
Improving outcomes in fistula intervention: A prospective, patient blinded, phase III, randomised controlled trial of drug eluting balloons in the angioplasty of native haemodialysis access arterio-venous fistula outflow stenosis
niversity Hospital Birmingham NHS Foundation Trust0 sites92 target enrollmentJanuary 20, 2016
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Renal failure
- Sponsor
- niversity Hospital Birmingham NHS Foundation Trust
- Enrollment
- 92
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis
- •2\. Fistula has been in use for at least 1 month and is more than 6 weeks old
- •3\. Brachiocephalic AV fistula
- •4\. Brachiobasilic AV fistula
- •5\. Radiocephalic AV fistula (both proximal and distal)
- •6\. Aged 18 years or over
- •7\. 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)
- •8\. Capacity to give valid informed consent
Exclusion Criteria
- •1\. Allergy to iodinated Intravenous contrast
- •2\. Allergy to Paclitaxel
- •3\. Prosthetic grafts
- •4\. Long or tandem lesions that cannot be treated with a single DEB
- •5\. Thrombosed ArterioVenous fistulas
- •6\. Women who are breastfeeding, pregnant or intending to become pregnant
- •7\. Participants of childbearing age who are unwilling to use a reliable form of contraception for the duration of the study
Outcomes
Primary Outcomes
Not specified
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