Drug Eluting Balloon Venoplasty in AV Fistula Stenosis (DeVA)

September 9, 2016 updated by: University Hospital Birmingham

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)

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Contact:
          • R G Jones, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Drug eluting angioplasty balloons
Device: Drug eluting balloons
Active Comparator: Control
Non-drug eluting balloons
Device: Non drug eluting balloons

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Time of baseline index intervention
Defined as <30% residual stenosis using only the study balloon to which the patient was randomised
Time of baseline index intervention
Assisted technical success of balloon angioplasty
Time Frame: At time of baseline index intervention
Defined as <30% residual stenosis using adjunctive procedures in addition to study balloon
At time of baseline index intervention
Successful use of fistula for dialysis
Time Frame: 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
In the 12 months following baseline index intervention
Secondary patency of the access circuit
Time Frame: In the 12 months following baseline index intervention
In the 12 months following baseline index intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Robert Jones, Dr, University Hospital Birmingham NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK5479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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