DeVA: Drug Eluting Balloon Venoplasty in AV Fistula Stenosis

Sponsor

University Hospital Birmingham (Other)

Overall Status

Unknown status

CT.gov ID

NCT02902094

Collaborator

Boston Scientific Corporation (Industry)

186

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Native Arteriovenous Fistula Stenosis	Device: Drug eluting balloons Device: Non drug eluting balloons	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

186 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patency [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Birmingham NHS Foundation Trust	Birmingham	West Midlands	United Kingdom	B15 2TH

Sponsors and Collaborators

University Hospital Birmingham
Boston Scientific Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Birmingham

ClinicalTrials.gov Identifier:

NCT02902094

Other Study ID Numbers:

RRK5479

First Posted:

Sep 15, 2016

Last Update Posted:

Sep 15, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Arteriovenous Fistula

Constriction, Pathologic

Fistula

Study Results

No Results Posted as of Sep 15, 2016