Drug Eluting Balloon Venoplasty in AV Fistula Stenosis

Stenosis Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02902094
• Other study ID #: RRK5479
• Status: Recruiting
• Phase: N/A
• First received: June 21, 2016
• Last updated: September 9, 2016
• Start date: January 2016
• Est. completion date: January 2019

Study information

• Verified date: September 2016
• Source: University Hospital Birmingham
• Contact: N E Anderson
• Phone: +441216272000
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Constriction, Pathologic
• Fistula
• Native Arteriovenous Fistula
• Stenosis

Intervention

Device:
• Drug eluting balloons

• Non drug eluting balloons

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Birmingham	Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Technical success	Defined as <30% residual stenosis using only the study balloon to which the patient was randomised	Time of baseline index intervention	No
Secondary	Assisted technical success of balloon angioplasty	Defined as <30% residual stenosis using adjunctive procedures in addition to study balloon	At time of baseline index intervention	No
Secondary	Successful use of fistula for dialysis	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	No
Secondary	Secondary patency of the access circuit		In the 12 months following baseline index intervention	No