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Arteriovenous FistulaPhase 3NCT02440022

Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

A Phase 3 study testing Lutonix DCB, Standard Balloon Angioplasty Catheter and Percutaneous Transluminal Angiography in people with Arteriovenous Fistula, run by C. R. Bard at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV)… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Arteriovenous Fistula
What is being tested?
Lutonix DCB, Standard Balloon Angioplasty Catheter and Percutaneous Transluminal Angiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
285 participants
Where
23 sitesUnited States
Study dates
Jun 2015to Jun 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥21 years;
  • The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF);
  • Arteriovenous fistula located in the arm;
  • Native AV fistula was created ≥30 days prior to the index procedure and has undergone one or more hemodialysis sessions;
  • Venous stenosis of an AV fistula with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.;
  • Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon;
  • Intended target lesion.

Who cannot join

  • Women who are pregnant, lactating, or planning on becoming pregnant during the study;
  • Hemodialysis access is located in the leg;
  • Subject has more than two lesions in the access circuit;
  • Subject has a secondary non-target lesion that cannot be successfully treated;
  • Target lesion is located central to the axillosubclavian junction;
  • The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction);
Show all 21Show fewer
  • A thrombosed access;
  • Surgical revision of the access site planned;
  • Recent prior surgical interventions of the access site;
  • Other planned treatment during the index procedure;
  • Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication;
  • Known contraindication (including allergic reaction) or sensitivity to paclitaxel.
  • Subjects who are taking immunosuppressive therapy or are routinely taking
  • ≥10mg of prednisone per day;
  • Subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol or confound the data interpretation;
  • Subject has a life expectancy <12 months;
  • Anticipated for a kidney transplant;
  • Anticipated conversion to peritoneal dialysis;
  • Subject has a stent located in the target or secondary non target lesion;
  • Subject has an infected AV access or systemic infection;
  • Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • The Board of Trustees of The University of Alabama for the University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Physicians Organizations, Inc.

    Boston, Massachusetts, 02114

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Rush University

    Chicago, Illinois, 60612

  • Michigan Vascular Center

    Flint, Michigan, 48507

  • Tarrant Vascular Clinic

    Fort Worth, Texas, 76104

  • Board of Regents of the University of Wisconsin System

    Madison, Wisconsin, 53715

  • University Vascular Access

    Memphis, Tennessee, 38115

  • Minnesota Vascular Surgery Center

    New Brighton, Minnesota, 55112

  • Nephrology Associates, P.A.

    Newark, Delaware, 19713

  • RenalCare Associates, S.C. d/b/a Illinois Kidney Disease & Hypertension Center

    Peoria, Illinois, 61603

  • Trustees of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC

    Phoenix, Arizona, 85012

  • Providence Interventional Associates, LLC

    Providence, Rhode Island, 02906

  • Capital Nephrology Associates, P.A.

    Raleigh, North Carolina, 27610

  • Capital Nephrology Medical Group

    Sacramento, California, 95825

  • San Antonio Kidney Disease Center Physicians Group, PLLC

    San Antonio, Texas, 78215

  • Spartanburg Regional Health Services District, Inc.

    Spartanburg, South Carolina, 29303

  • Renal and Transplant Associates of New England, PC

    Springfield, Massachusetts, 01107

  • Southwest Clinical Research Institute, LLC

    Tempe, Arizona, 85284

  • Oklahoma Life Access, PLLC

    Tulsa, Oklahoma, 74104

  • MakrisMD, LLC, d/b/a Chicago Access Care

    Westmont, Illinois, 60559

Other trials in United States

About this study

Official title: A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing Lutonix® 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Being tested
Lutonix DCB, Standard Balloon Angioplasty Catheter, Percutaneous Transluminal Angiography
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 DCBCombination product

  • Standard Balloon Angioplasty CatheterDevice

  • Percutaneous Transluminal AngiographyProcedure or surgery

    Also called PTA

    Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Study groups in NCT02440022
Study groupRoleWhat they receive
Lutonix DCBExperimentalPercutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.
Receives: Combination Product: Lutonix DCB; Procedure: Percutaneous Transluminal Angiography
Standard Balloon Angioplasty CatheterActive comparatorPercutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Receives: Device: Standard Balloon Angioplasty Catheter; Procedure: Percutaneous Transluminal Angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure

    Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.

    Measured: 6 months post index procedure

  2. Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.

    The primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggests the involvement of the AV access circuit (CEC adjudicated).

    Measured: 30 Days Post Index Procedure

Secondary outcomes (8)

  1. Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months

    Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.

    Measured: 3, 9, 12, 18, and 24 Months Post Index Procedure

  2. Percentage of Participants With Device, Procedural and Clinical Success

    • Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure.
    • 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).
    • Clinical Success: The resumption of dialysis for at least one session after the index procedure.

    Measured: Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure

  3. Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

    Index access site abandonment refers to an abandonment due to either receiving a kidney transplant, converting to Peritoneal Dialysis, or a new access site being created.

    Measured: 3, 6, 9, 12, 18 and 24 Months Post Index Procedure

  4. Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

    Measured: 3, 6, 9, 12, 18 and 24 Months Post Index Procedure

  5. Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated)

    Events adjudicated as 'definitely related' and 'possibly related' by the CEC were combined in all analyses and are displayed as 'related' in this report.

    Measured: 1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure

  6. Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure

    Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.

    Measured: 6 Months Post Index Procedure

  7. Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

    Measured: 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

  8. Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

    Measured: 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionSep 2016
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02440022
Sponsor's protocol ID
CL0023-01
Status last verified
Apr 2020
First submitted
7 May 2015
Last updated
6 May 2020
Data monitoring committee
Yes

Publications

  • Trerotola SO, Lawson J, Roy-Chaudhury P, Saad TF; Lutonix AV Clinical Trial Investigators. Drug Coated Balloon Angioplasty in Failing AV Fistulas: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2018 Aug 7;13(8):1215-1224. doi: 10.2215/CJN.14231217. Epub 2018 Jul 24.

    PubMed 30042225

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lutonix DCB, Standard Balloon Angioplasty Catheter and Percutaneous Transluminal Angiography in people with Arteriovenous Fistula, run by C. R. Bard at 23 sites in United States.

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 7 inclusion and 21 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 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure (time frame: 6 months post index procedure). 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?

On the ClinicalTrials.gov record for NCT02440022, which also lists 1 linked publication.

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 6 May 2020.

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