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Lutonix® Global AV Registry (AVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02746159
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : April 10, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Arteriovenous Fistula Device: Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004

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Study Type : Observational [Patient Registry]
Actual Enrollment : 324 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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 AV Fistulae
Actual Study Start Date : June 2016
Actual Primary Completion Date : September 18, 2018
Actual Study Completion Date : March 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Primary Outcome Measures :
  1. Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit [ Time Frame: 30 days. ]
  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Proportion of Subjects with Abandonment of permanent access in the index extremity [ Time Frame: 12 months ]
  4. 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.

  5. 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).

  6. Proportion of Subjects with Clinical Success [ Time Frame: 12 Months ]
    The resumption of dialysis for at least one session after the index procedure.

  7. Rate of device and procedure related adverse events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm.

Inclusion Criteria:

  1. Male or non-pregnant, non-breastfeeding female ≥18 years of age;
  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:

Patients will be excluded if ANY of the following conditions apply:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02746159

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LKH Graz
Graz, Austria, A-8036
Clinique du Pré
Le Mans, France, 72018
Clinique Les Fontaines
Melun, France, 77000
Institut Montsouris
Paris, France, 75014
Uniklinik Giessen und Marburg
Giessen, Germany, 35392
Universitätsklinikum Jena
Jena, Germany, 07743
University Hospital of Patras
Patras, Greece, 26504
Casa Di Cura Maria Rosaria
Pompei, Italy, 80045
University of Insubria
Varese, Italy, 21100
Klinika Chirurgii Naczyniowej University Hospital nr 1
Lublin, Poland, 20-081
Hospital da Cruz Vermelha
Lisboa, Portugal, 1549-008
NephroCare Portugal, S.A. NephroCare Lumia
Lisboa, Portugal, 1750-130
National University Hospital
Singapore, Singapore, 119228
Singapore General Hospital
Singapore, Singapore, 169856
Ospedale Regionale di Lugano
Lugano, Switzerland, 6903
United Kingdom
Lister Hospital
Leicester, United Kingdom, SG1 4AB
Barts and The Royal London Hospital
London, United Kingdom, E1 1BB
Royal Berkshire hospital
Reading, United Kingdom, RG1 5AN
Sponsors and Collaborators
C. R. Bard
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Principal Investigator: Dimitrios Karnabatidis, MD, PhD University Hospital of Patras, Radiology Department

Additional Information:

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Responsible Party: C. R. Bard Identifier: NCT02746159     History of Changes
Other Study ID Numbers: CL0026-01
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities