Clinical Trial: Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing Lutonix® 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional

Brief Summary: This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Detailed Summary:
Sponsor: C. R. Bard

Current Primary Outcome:

  • Efficacy: Primary Patency [ Time Frame: 6 months ]
    Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.
  • Safety: Freedom from any serious adverse event(s) involving the AV access circuit. [ Time Frame: 30 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Target Lesion Primary Patency [ Time Frame: 12 months ]
  • Number of interventions, required to maintain target lesion patency [ Time Frame: 12 months ]
  • Access Circuit Primary Patency [ Time Frame: 6 months ]
  • Access Circuit Primary Patency [ Time Frame: 12 months ]
  • Target Lesion Primary Patency [ Time Frame: 3, 9, 18 and 24 months ]
  • Access Circuit Primary Patency [ Time Frame: 3, 9, 18 and 24 months ]
  • Device, Procedural and Clinical Success [ Time Frame: 24 months ]
    • Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure.
    • Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs).
    • Clinical Success: The resumption of dialysis for at least one session after the index procedure.
  • Target Lesion Primary Patency [ Time Frame: 6 months ]
    Target Lesion Primary Patency evaluated for subjects in whom a fiber pre-dilation balloon was used before the Lutonix AV DCB as compared to those in whom a non-fiber pre-dilation balloon.
  • Abandonment of permanent access in the index extremity [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
    The index access site is abandoned and a new access site is created.
  • Number of interventions, required to maintain access circuit patency [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
  • Number of interventions, required to maintain target lesion patency [ Time Frame: 3, 6, 9, 18 and 24 months ]
  • Rate of device and procedure related adverse events [ Time Frame: 1, 3, 6, 9, 12, 18 and 24 months ]


Original Secondary Outcome:

  • Target Lesion Primary Patency [ Time Frame: 12 months ]
  • Number of interventions, required to maintain target lesion patency [ Time Frame: 12 months ]
  • Access Circuit Primary Patency [ Time Frame: 6 months ]
  • Access Circuit Primary Patency [ Time Frame: 12 months ]
  • Target Lesion Primary Patency [ Time Frame: 3, 9, 18 and 24 months ]
  • Access Circuit Primary Patency [ Time Frame: 3, 9, 18 and 24 months ]
  • Device, Procedural and Clinical Success [ Time Frame: 24 months ]
    • Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure.
    • Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs).
    • Clinical Success: The resumption of dialysis for at least one session after the index procedure.
  • Abandonment of permanent access in the index extremity [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
    The index access site is abandoned and a new access site is created.
  • Number of interventions, required to maintain access circuit patency [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
  • Number of interventions, required to maintain target lesion patency [ Time Frame: 3, 6, 9, 18 and 24 months ]
  • Rate of device and procedure related adverse events [ Time Frame: 1, 3, 6, 9, 12, 18 and 24 months ]


Information By: C. R. Bard

Dates:
Date Received: May 7, 2015
Date Started: June 2015
Date Completion: September 2018
Last Updated: May 18, 2017
Last Verified: May 2017