Arteriovenous FistulaAVRNCT02746159
Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
An observational study of Arteriovenous Fistula, run by C. R. Bard at 26 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004
- Type of treatment
- Medical device
- How many people
- 320 participants
- Where
- 26 sitesin 13 countries
- Study dates
- 7 Jun 2016to 9 Mar 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 13 countries.
26 sites in 13 countries
Italy4 sites
Azienda Ospedaliera Di Pisa - Ospedale Cisanello
Pisa
Casa Di Cura Maria Rosaria
Pompei, 80045
San Giovanni Bosco
Torino
University of Insubria
Varese, 21100
Taiwan4 sites
Buddhist Dalin Tzuchi hospital
Dalin
Chang-Gung Memorial Hospital
Linkou District
Hsin Kong Wu Ho-Su Memorial Hospital
Taipei
Taipei Tzu Chi Hospital
Taipei
France3 sites
Clinique du Pré
Le Mans, 72018
Clinique Les Fontaines
Melun, 77000
Institut Montsouris
Paris, 75014
United Kingdom3 sites
Lister Hospital
Leicester, SG1 4AB
Barts and The Royal London Hospital
London, E1 1BB
Royal Berkshire hospital
Reading, RG1 5AN
Germany2 sites
Uniklinik Giessen und Marburg
Giessen, 35392
Universitätsklinikum Jena
Jena, 07743
Portugal2 sites
Hospital da Cruz Vermelha
Lisbon, 1549-008
NephroCare Portugal, S.A. NephroCare Lumia
Lisbon, 1750-130
Singapore2 sites
National University Hospital
Singapore, 119228
Singapore General Hospital
Singapore, 169856
Poland1 site
Klinika Chirurgii Naczyniowej University Hospital nr 1
Lublin, 20-081
Saudi Arabia1 site
King Abdullah International Medical Research Center
Riyadh
About this study
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
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.
Read the 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.
- Conditions
- Arteriovenous Fistula
- Being tested
- Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit
Primary safety events include any serious adverse event(s) involving the AV access circuit
Measured: 30 days.
Proportion of subjects with target lesion primary patency
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.
Measured: 6 Months
Secondary outcomes (7)
Proportion of subjects with access circuit primary patency at 3, 6, and 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.
Measured: 12 months
Proportion of Subjects withTarget Lesion Primary Patency (TLPP)
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.
Measured: 12 months
Proportion of Subjects with Abandonment of permanent access in the index extremity
The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning.
Measured: 12 months
Proportion of Subjects with Device Success
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.
Measured: 12 Months
Proportion of Subjects with Procedural Success
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).
Measured: 12 Months
Proportion of Subjects with Clinical Success
The resumption of dialysis for at least one session after the index procedure.
Measured: 12 Months
Rate of device and procedure related adverse events
Freedom from device-related or procedure-related serious adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start7 Jun 2016
- Primary completion18 Sep 2018
- Study completion9 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dimitrios Karnabatidis, MD, PhD, Principal investigator, University Hospital of Patras, Radiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746159
- Sponsor's protocol ID
- CL0026-01
- Acronym
- AVR
- Status last verified
- Aug 2019
- First submitted
- 18 Apr 2016
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02746159
- Acronym / sponsor ID
- AVR / CL0026-01
- Conditions
- Arteriovenous Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 9 Mar 2019 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004 | Device | – |
Primary outcome
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
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.
7 secondary outcomes
Proportion of subjects with access circuit primary patency at 3, 6, and 12 months
Time frame: 12 months
Proportion of Subjects withTarget Lesion Primary Patency (TLPP)
Time frame: 12 months
Proportion of Subjects with Abandonment of permanent access in the index extremity
Time frame: 12 months
Proportion of Subjects with Device Success
Time frame: 12 Months
Proportion of Subjects with Procedural Success
Time frame: 12 Months
Proportion of Subjects with Clinical Success
Time frame: 12 Months
Rate of device and procedure related adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Karnabatidis, MD, PhD principal investigator
University Hospital of Patras, Radiology Department
26 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula, run by C. R. Bard at 26 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Italy, Taiwan, France, United Kingdom, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit (time frame: 30 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.