Clinical Trial: Drug Eluting Balloon Venoplasty in AV Fistula Stenosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: University Hospital Birmingham
Current Primary Outcome: Patency [ Time Frame: 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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Technical success [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: In the 12 months following baseline index intervention ]
Original Secondary Outcome: Same as current
Information By: University Hospital Birmingham
Dates:
Date Received: June 21, 2016
Date Started: January 2016
Date Completion: January 2019
Last Updated: September 9, 2016
Last Verified: September 2016