Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
- Conditions
- Arteriovenous Fistula
- Registration Number
- NCT02746159
- Lead Sponsor
- C. R. Bard
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- Male or non-pregnant, non-breastfeeding female ≥18 years of age;
- Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
- Native or synthetic (grafts) arteriovenous fistula located in the arm, including central veins, presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines; and
- Lesion(s) can be treated with available Lutonix DCB device size matrix per current IFU.
Patients will be excluded if ANY of the following conditions apply:
- Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix Global AV registry).
- Patient has a non-controllable allergy to contrast; or
- Patient has another medical condition that, which in the opinion of the Investigator, may confound the data interpretation of is associated with a life expectancy insufficient to allow for completion of patient registry procedure and follow up.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects with target lesion primary patency 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.Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit 30 days. Primary safety events include any serious adverse event(s) involving the AV access circuit
- Secondary Outcome Measures
Name Time Method Proportion of subjects with access circuit primary patency at 3, 6, and 12 months 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 with Device Success 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 Abandonment of permanent access in the index extremity 12 months The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning.
Proportion of Subjects withTarget Lesion Primary Patency (TLPP) 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 Procedural Success 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 12 Months The resumption of dialysis for at least one session after the index procedure.
Rate of device and procedure related adverse events 12 months Freedom from device-related or procedure-related serious adverse events
Trial Locations
- Locations (26)
LKH Graz
🇦🇹Graz, Austria
University Hospital of Patras
🇬🇷Patras, Greece
Clinique Les Fontaines
🇫🇷Melun, France
Azienda Ospedaliera Di Pisa - Ospedale Cisanello
🇮🇹Pisa, Italy
Uniklinik Giessen und Marburg
🇩🇪Giessen, Germany
Institut Montsouris
🇫🇷Paris, France
Clinique du Pré
🇫🇷Le Mans, France
Casa Di Cura Maria Rosaria
🇮🇹Pompei, Italy
Universitätsklinikum Jena
🇩🇪Jena, Germany
Klinika Chirurgii Naczyniowej University Hospital nr 1
🇵🇱Lublin, Poland
University of Insubria
🇮🇹Varese, Italy
San Giovanni Bosco
🇮🇹Torino, Italy
Hospital da Cruz Vermelha
🇵🇹Lisboa, Portugal
NephroCare Portugal, S.A. NephroCare Lumia
🇵🇹Lisboa, Portugal
Singapore General Hospital
🇸🇬Singapore, Singapore
King Abdullah International Medical Research Center
🇸🇦Riyadh, Saudi Arabia
National University Hospital
🇸🇬Singapore, Singapore
Ospedale Regionale di Lugano
🇨🇭Lugano, Switzerland
Chang-Gung Memorial Hospital
🇨🇳Linkou, Taiwan
Buddhist Dalin Tzuchi hospital
🇨🇳Dalin, Taiwan
Taipei Tzu Chi Hospital
🇨🇳Taipei, Taiwan
Hsin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan
Lister Hospital
🇬🇧Leicester, United Kingdom
Royal Berkshire hospital
🇬🇧Reading, United Kingdom
Barts and The Royal London Hospital
🇬🇧London, United Kingdom
Ankara Baskent University
🇹🇷Ankara, Turkey