Drug Eluting Balloon Venoplasty in AV Fistula Stenosis (DeVA)

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status: Unknown

Conditions: Native Arteriovenous Fistula; Stenosis

Treatments: Device: Drug eluting balloons; Device: Non drug eluting balloons

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02902094

RRK5479

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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186 participants in 2 patient groups

Experimental

Experimental group

Description:

Drug eluting angioplasty balloons

Treatment:

Device: Drug eluting balloons

Control

Active Comparator group

Description:

Non-drug eluting balloons

Treatment:

Device: Non drug eluting balloons