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
About this trial
This is an interventional treatment trial for Native Arteriovenous Fistula
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.
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
NCT ID
NCT02902094
First Posted
June 21, 2016
Last Updated
September 9, 2016
Sponsor
University Hospital Birmingham
Collaborators
Boston Scientific Corporation
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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