Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae (AVR)

February 21, 2023 updated by: C. R. Bard

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Graz, Austria, A-8036
        • LKH Graz
      • Le Mans, France, 72018
        • Clinique du Pré
      • Melun, France, 77000
        • Clinique les Fontaines
      • Paris, France, 75014
        • Institut Montsouris
      • Giessen, Germany, 35392
        • Uniklinik Giessen und Marburg
      • Jena, Germany, 07743
        • Universitätsklinikum Jena
      • Patras, Greece, 26504
        • University Hospital of Patras
      • Pisa, Italy
        • Azienda Ospedaliera Di Pisa - Ospedale Cisanello
      • Pompei, Italy, 80045
        • Casa Di Cura Maria Rosaria
      • Torino, Italy
        • San Giovanni Bosco
      • Varese, Italy, 21100
        • University of Insubria
      • Lublin, Poland, 20-081
        • Klinika Chirurgii Naczyniowej University Hospital nr 1
      • Lisboa, Portugal, 1549-008
        • Hospital da Cruz Vermelha
      • Lisboa, Portugal, 1750-130
        • NephroCare Portugal, S.A. NephroCare Lumia
      • Riyadh, Saudi Arabia
        • King Abdullah International Medical Research Center
      • Singapore, Singapore, 119228
        • National University Hospital
      • Singapore, Singapore, 169856
        • Singapore General Hospital
      • Lugano, Switzerland, 6903
        • Ospedale Regionale di Lugano
      • Dalin, Taiwan
        • Buddhist Dalin Tzuchi hospital
      • Linkou, Taiwan
        • Chang-Gung Memorial Hospital
      • Taipei, Taiwan
        • Hsin Kong Wu Ho-Su Memorial Hospital
      • Taipei, Taiwan
        • Taipei Tzu Chi Hospital
      • Ankara, Turkey
        • Ankara Baskent University
      • Leicester, United Kingdom, SG1 4AB
        • Lister Hospital
      • London, United Kingdom, E1 1BB
        • Barts and The Royal London Hospital
      • Reading, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit
Time Frame: 30 days.
Primary safety events include any serious adverse event(s) involving the AV access circuit
30 days.
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.

6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
Proportion of Subjects with Abandonment of permanent access in the index extremity
Time Frame: 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.
12 months
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.
12 Months
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).
12 Months
Proportion of Subjects with Clinical Success
Time Frame: 12 Months
The resumption of dialysis for at least one session after the index procedure.
12 Months
Rate of device and procedure related adverse events
Time Frame: 12 months
Freedom from device-related or procedure-related serious adverse events
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Dimitrios Karnabatidis, MD, PhD, University Hospital of Patras, Radiology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2016

Primary Completion (Actual)

September 18, 2018

Study Completion (Actual)

March 9, 2019

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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