Drug Eluting Balloon Venoplasty in AV Fistula Stenosis

Not Applicable

• Conditions: Stenosis; Native Arteriovenous Fistula
• Interventions: Device: Non drug eluting balloons; Device: Drug eluting balloons

• Registration Number: NCT02902094
• Lead Sponsor: University Hospital Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-06-21
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-09
• Last Update Submitted: 2016-09-09
• Study First Posted: 2016-09-15
• Last Update Posted: 2016-09-15
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Non drug eluting balloons	Non-drug eluting balloons
Experimental	Drug eluting balloons	Drug eluting angioplasty balloons

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom