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

April 27, 2020 updated by: C. R. Bard

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
285

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC
      • Tempe, Arizona, United States, 85284
        • Southwest Clinical Research Institute, LLC
    • California
      • Sacramento, California, United States, 95825
        • Capital Nephrology Medical Group
    • Delaware
      • Newark, Delaware, United States, 19713
        • Nephrology Associates, P.A.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University
      • Peoria, Illinois, United States, 61603
        • RenalCare Associates, S.C. d/b/a Illinois Kidney Disease & Hypertension Center
      • Westmont, Illinois, United States, 60559
        • MakrisMD, LLC, d/b/a Chicago Access Care
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Physicians Organizations, Inc.
      • Springfield, Massachusetts, United States, 01107
        • Renal and Transplant Associates of New England, PC
    • Michigan
      • Flint, Michigan, United States, 48507
        • Michigan Vascular Center
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Minnesota Vascular Surgery Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Capital Nephrology Associates, P.A.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Life Access, PLLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Trustees of the University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Providence Interventional Associates, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Health Services District, Inc.
    • Tennessee
      • Memphis, Tennessee, United States, 38115
        • University Vascular Access
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Tarrant Vascular Clinic
      • San Antonio, Texas, United States, 78215
        • San Antonio Kidney Disease Center Physicians Group, PLLC
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Board of Regents of the University of Wisconsin System

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥21 years;
  2. 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);
  3. Arteriovenous fistula located in the arm;
  4. Native AV fistula was created ≥30 days prior to the index procedure and has undergone one or more hemodialysis sessions;
  5. 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.;
  6. Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon;
  7. Intended target lesion.

Exclusion Criteria:

  1. Women who are pregnant, lactating, or planning on becoming pregnant during the study;
  2. Hemodialysis access is located in the leg;
  3. Subject has more than two lesions in the access circuit;
  4. Subject has a secondary non-target lesion that cannot be successfully treated;
  5. Target lesion is located central to the axillosubclavian junction;
  6. The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction);
  7. A thrombosed access;
  8. Surgical revision of the access site planned;
  9. Recent prior surgical interventions of the access site;
  10. Other planned treatment during the index procedure;
  11. Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication;
  12. Known contraindication (including allergic reaction) or sensitivity to paclitaxel.

  13. Subjects who are taking immunosuppressive therapy or are routinely taking

    ≥10mg of prednisone per day;

  14. 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;
  15. Subject has a life expectancy <12 months;
  16. Anticipated for a kidney transplant;
  17. Anticipated conversion to peritoneal dialysis;
  18. Subject has a stent located in the target or secondary non target lesion;
  19. Subject has an infected AV access or systemic infection;
  20. Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lutonix DCB
Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.
Combination product: Lutonix DCB
Procedure: Percutaneous Transluminal Angiography
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.
Other Names:
  • PTA
Active Comparator: Standard Balloon Angioplasty Catheter
Percutaneous 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.
Procedure: Percutaneous Transluminal Angiography
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.
Other Names:
  • PTA
Device: Standard Balloon Angioplasty Catheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure
Time Frame: 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.
6 months post index procedure
Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.
Time Frame: 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).
30 Days Post Index Procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months
Time Frame: 3, 9, 12, 18, and 24 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.
3, 9, 12, 18, and 24 Months Post Index Procedure
Percentage of Participants With Device, Procedural and Clinical Success
Time Frame: Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure
  • 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.
Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure
Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
Time Frame: 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.
3, 6, 9, 12, 18 and 24 Months Post Index Procedure
Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
Time Frame: 3, 6, 9, 12, 18 and 24 Months Post Index Procedure
3, 6, 9, 12, 18 and 24 Months Post Index Procedure
Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated)
Time Frame: 1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure
Events adjudicated as 'definitely related' and 'possibly related' by the CEC were combined in all analyses and are displayed as 'related' in this report.
1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure
Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure
Time Frame: 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.
6 Months Post Index Procedure
Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
Time Frame: 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
3, 6, 9, 12, 18, and 24 Months Post Index Procedure
Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
Time Frame: 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. R. Bard

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Trerotola, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL0023-01

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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