- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746159
Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae (AVR)
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 AV Fistulae
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Graz, Austria, A-8036
- LKH Graz
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Le Mans, France, 72018
- Clinique du Pré
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Melun, France, 77000
- Clinique les Fontaines
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Paris, France, 75014
- Institut Montsouris
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Giessen, Germany, 35392
- Uniklinik Giessen und Marburg
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Jena, Germany, 07743
- Universitätsklinikum Jena
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Patras, Greece, 26504
- University Hospital of Patras
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Pisa, Italy
- Azienda Ospedaliera Di Pisa - Ospedale Cisanello
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Pompei, Italy, 80045
- Casa Di Cura Maria Rosaria
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Torino, Italy
- San Giovanni Bosco
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Varese, Italy, 21100
- University of Insubria
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Lublin, Poland, 20-081
- Klinika Chirurgii Naczyniowej University Hospital nr 1
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Lisboa, Portugal, 1549-008
- Hospital da Cruz Vermelha
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Lisboa, Portugal, 1750-130
- NephroCare Portugal, S.A. NephroCare Lumia
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Riyadh, Saudi Arabia
- King Abdullah International Medical Research Center
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Singapore, Singapore, 119228
- National University Hospital
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Singapore, Singapore, 169856
- Singapore General Hospital
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Lugano, Switzerland, 6903
- Ospedale Regionale di Lugano
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Dalin, Taiwan
- Buddhist Dalin Tzuchi hospital
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Linkou, Taiwan
- Chang-Gung Memorial Hospital
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Taipei, Taiwan
- Hsin Kong Wu Ho-Su Memorial Hospital
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Taipei, Taiwan
- Taipei Tzu Chi Hospital
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Ankara, Turkey
- Ankara Baskent University
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Leicester, United Kingdom, SG1 4AB
- Lister Hospital
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London, United Kingdom, E1 1BB
- Barts and The Royal London Hospital
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Reading, United Kingdom, RG1 5AN
- Royal Berkshire Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit
Time Frame: 30 days.
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Primary safety events include any serious adverse event(s) involving the AV access circuit
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30 days.
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Proportion of subjects with target lesion primary patency
Time Frame: 6 Months
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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. |
6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of subjects with access circuit primary patency at 3, 6, and 12 months
Time Frame: 12 months
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Interval following intervention until the next access circuit thrombosis or repeated intervention.
Ends with treatment of a lesion anywhere within the access circuit.
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12 months
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Proportion of Subjects withTarget Lesion Primary Patency (TLPP)
Time Frame: 12 months
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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.
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12 months
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Proportion of Subjects with Abandonment of permanent access in the index extremity
Time Frame: 12 months
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The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning.
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12 months
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Proportion of Subjects with Device Success
Time Frame: 12 Months
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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.
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12 Months
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Proportion of Subjects with Procedural Success
Time Frame: 12 Months
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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).
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12 Months
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Proportion of Subjects with Clinical Success
Time Frame: 12 Months
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The resumption of dialysis for at least one session after the index procedure.
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12 Months
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Rate of device and procedure related adverse events
Time Frame: 12 months
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Freedom from device-related or procedure-related serious adverse events
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dimitrios Karnabatidis, MD, PhD, University Hospital of Patras, Radiology Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL0026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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