NCT02902094

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

June 21, 2016

Last Update Submit

September 9, 2016

Conditions

Native Arteriovenous FistulaStenosis

Outcome Measures

Primary Outcomes (1)

  • Patency

    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 Outcomes (4)

  • Technical success

    Time of baseline index intervention

  • Assisted technical success of balloon angioplasty

    At time of baseline index intervention

  • Successful use of fistula for dialysis

    In the 12 months following baseline index intervention

  • Secondary patency of the access circuit

    In the 12 months following baseline index intervention

Study Arms (2)

Experimental

EXPERIMENTAL

Drug eluting angioplasty balloons

Device: Drug eluting balloons

Control

ACTIVE COMPARATOR

Non-drug eluting balloons

Device: Non drug eluting balloons

Interventions

Drug eluting balloonsDEVICE
Experimental
Non drug eluting balloonsDEVICE
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Jones, Dr

    University Hospital Birmingham NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

N E Anderson

CONTACT

+441216272000

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

September 15, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

September 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)