Clinical Trial: Lutonix® Global AV Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for Treatment of Dysfunctional Native and Synthetic

Brief Summary: The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.

Detailed Summary:
Sponsor: C. R. Bard

Current Primary Outcome:

  • Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit [ Time Frame: 30 days. ]
  • Proportion of subjects with target lesion primary patency [ Time Frame: 6 Months ]

    Defined as the interval following index procedure until clinically-driven reintervention of the target lesion or access thrombosis, through 6 months.

    Clinically-driven reintervention is defined as a lesion that has ≥50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of subjects with access circuit primary patency at 3, 6, and 12 months [ Time Frame: 12 months ]
    Interval following intervention until the next access circuit thrombosis or repeated intervention. Ends with treatment of a lesion anywhere within the access circuit.
  • Proportion of Subjects withTarget Lesion Primary Patency (TLPP) [ Time Frame: 12 months ]
    Target Lesion Primary Patency (TLPP) is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.
  • Proportion of Subjects with Abandonment of permanent access in the index extremity [ Time Frame: 12 months ]
  • Proportion of Subjects with Device Success [ Time Frame: 12 Months ]
    Successful delivery to the target lesion, deployment, and retrieval at index procedure. If a device is inserted into the subject but not used due to user error (e.g. inappropriate balloon length or transit time too long), this device will not be included in the device success assessment.
  • Proportion of Subjects with Procedural Success [ Time Frame: 12 Months ]
    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).
  • Proportion of Subjects with Clinical Success [ Time Frame: 12 Months ]
    The resumption of dialysis for at least one session after the index procedure.
  • Rate of device and procedure related adverse events [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: C. R. Bard

Dates:
Date Received: April 18, 2016
Date Started: June 2016
Date Completion: March 2019
Last Updated: March 24, 2017
Last Verified: March 2017