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