NCT02902094

Drug Eluting Balloon Venoplasty in AV Fistula Stenosis

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: University Hospital Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Native Arteriovenous Fistula
• Stenosis

Interventions

Type	Name	Description
DEVICE	Drug eluting balloons
DEVICE	Non drug eluting balloons

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-09-15
• Last updated: 2016-09-15

Locations

1 site across 1 country: United Kingdom