Drug Eluting Balloon Venoplasty in AV Fistula Stenosis (DeVA)

U

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

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

Trial contacts and locations

0

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Central trial contact

N E Anderson

Data sourced from clinicaltrials.gov

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