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.
This post market registry is intended to demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB in a heterogeneous patient population with dysfunctional native or synthetic AV fistulae in real world clinical practice.
Study Type
OBSERVATIONAL
Enrollment
320
LKH Graz
Graz, Austria
Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit
Primary safety events include any serious adverse event(s) involving the AV access circuit
Time frame: 30 days.
Proportion of subjects with target lesion primary patency
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.
Time frame: 6 Months
Proportion of subjects with access circuit primary patency at 3, 6, and 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.
Time frame: 12 months
Proportion of Subjects withTarget Lesion Primary Patency (TLPP)
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.
Time frame: 12 months
Proportion of Subjects with Abandonment of permanent access in the index extremity
The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning.
Time frame: 12 months
Proportion of Subjects with Device Success
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinique du Pré
Le Mans, France
Clinique Les Fontaines
Melun, France
Institut Montsouris
Paris, France
Uniklinik Giessen und Marburg
Giessen, Germany
Universitätsklinikum Jena
Jena, Germany
University Hospital of Patras
Pátrai, Greece
Azienda Ospedaliera Di Pisa - Ospedale Cisanello
Pisa, Italy
Casa Di Cura Maria Rosaria
Pompei, Italy
San Giovanni Bosco
Torino, Italy
...and 16 more locations
Time frame: 12 Months
Proportion of Subjects with 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).
Time frame: 12 Months
Proportion of Subjects with Clinical Success
The resumption of dialysis for at least one session after the index procedure.
Time frame: 12 Months
Rate of device and procedure related adverse events
Freedom from device-related or procedure-related serious adverse events
Time frame: 12 months