Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
NCT ID: NCT02746159
Last Updated: 2023-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
320 participants
OBSERVATIONAL
2016-06-07
2019-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004
Eligibility Criteria
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Inclusion Criteria
2. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
3. 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
4. Lesion(s) can be treated with available Lutonix DCB device size matrix per current IFU.
Exclusion Criteria
1. 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).
2. Patient has a non-controllable allergy to contrast; or
3. 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.
18 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Dimitrios Karnabatidis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Patras, Radiology Department
Locations
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LKH Graz
Graz, , Austria
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
University of Insubria
Varese, , Italy
Klinika Chirurgii Naczyniowej University Hospital nr 1
Lublin, , Poland
Hospital da Cruz Vermelha
Lisbon, , Portugal
NephroCare Portugal, S.A. NephroCare Lumia
Lisbon, , Portugal
King Abdullah International Medical Research Center
Riyadh, , Saudi Arabia
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Ospedale Regionale di Lugano
Lugano, , Switzerland
Buddhist Dalin Tzuchi hospital
Dalin, , Taiwan
Chang-Gung Memorial Hospital
Linkou District, , Taiwan
Hsin Kong Wu Ho-Su Memorial Hospital
Taipei, , Taiwan
Taipei Tzu Chi Hospital
Taipei, , Taiwan
Ankara Baskent University
Ankara, , Turkey (Türkiye)
Lister Hospital
Leicester, , United Kingdom
Barts and The Royal London Hospital
London, , United Kingdom
Royal Berkshire hospital
Reading, , United Kingdom
Countries
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Other Identifiers
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CL0026-01
Identifier Type: -
Identifier Source: org_study_id
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