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

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: Completed
• Conditions: Arteriovenous Fistula
• Intervention / Treatment: Combination product: Lutonix DCB; Procedure: Percutaneous Transluminal Angiography; Device: Standard Balloon Angioplasty Catheter

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 19 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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

Outcome Measure	Measure Description	Time Frame
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.	3, 9, 12, 18, and 24 Months Post Index Procedure
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.	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	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		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)	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	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		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		1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Scott Trerotola, MD, University of Pennsylvania

Publications and helpful links

General 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. Erratum In: Clin J Am Soc Nephrol. 2019 Jul 5;14(7):1073.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 11, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: CL0023-01