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Drug Eluting Balloon Venoplasty in AV Fistula Stenosis (DeVA)

Primary Purpose

Native Arteriovenous Fistula, Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Drug eluting balloons
Non drug eluting balloons
Sponsored by
University Hospital Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Native Arteriovenous Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospitals Birmingham NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

Drug eluting angioplasty balloons

Non-drug eluting balloons

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Technical success
Defined as <30% residual stenosis using only the study balloon to which the patient was randomised
Assisted technical success of balloon angioplasty
Defined as <30% residual stenosis using adjunctive procedures in addition to study balloon
Successful use of fistula for dialysis
Defined as successful use of the fistula for dialysis using 2 needles on at least one occasion
Secondary patency of the access circuit

Full Information

First Posted
June 21, 2016
Last Updated
September 9, 2016
Sponsor
University Hospital Birmingham
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02902094
Brief Title
Drug Eluting Balloon Venoplasty in AV Fistula Stenosis
Acronym
DeVA
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Birmingham
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Native Arteriovenous Fistula, Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Drug eluting angioplasty balloons
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Non-drug eluting balloons
Intervention Type
Device
Intervention Name(s)
Drug eluting balloons
Intervention Type
Device
Intervention Name(s)
Non drug eluting balloons
Primary Outcome Measure Information:
Title
Patency
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technical success
Description
Defined as <30% residual stenosis using only the study balloon to which the patient was randomised
Time Frame
Time of baseline index intervention
Title
Assisted technical success of balloon angioplasty
Description
Defined as <30% residual stenosis using adjunctive procedures in addition to study balloon
Time Frame
At time of baseline index intervention
Title
Successful use of fistula for dialysis
Description
Defined as successful use of the fistula for dialysis using 2 needles on at least one occasion
Time Frame
In the 12 months following baseline index intervention
Title
Secondary patency of the access circuit
Time Frame
In the 12 months following baseline index intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
N E Anderson
Phone
+441216272000
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jones, Dr
Organizational Affiliation
University Hospital Birmingham NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R G Jones, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Drug Eluting Balloon Venoplasty in AV Fistula Stenosis

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