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

Phase 3

Completed

• Conditions: Arteriovenous Fistula
• Interventions: Combination Product: Lutonix DCB; Device: Standard Balloon Angioplasty Catheter; Procedure: Percutaneous Transluminal Angiography

• Registration Number: NCT02440022
• Lead Sponsor: C. R. Bard

Brief 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) fistulae located in the upper extremity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-12
• Study Start: 2015-06
• Primary Completion: 2016-09
• Disposition First Submitted: 2017-08-09
• Disposition First Submitted QC: 2017-08-09
• Disposition First Posted: 2017-08-11
• Study Completion: 2018-06
• Results First Submitted: 2020-02-25
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Results First Posted: 2020-05-06
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lutonix DCB	Percutaneous Transluminal Angiography	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.
Lutonix DCB	Lutonix DCB	Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.
Standard Balloon Angioplasty Catheter	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.
Standard Balloon Angioplasty Catheter	Percutaneous Transluminal Angiography	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure	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.
Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.	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).

Secondary Outcome Measures

Name	Time	Method
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)	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.
Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure	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.
Percentage of Participants With Device, Procedural and Clinical Success	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.
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
Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months	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.
Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure	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.
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

Trial Locations

Locations (23)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Rush University; 🇺🇸 Chicago, Illinois, United States

Michigan Vascular Center; 🇺🇸 Flint, Michigan, United States

Minnesota Vascular Surgery Center; 🇺🇸 New Brighton, Minnesota, United States

Tarrant Vascular Clinic; 🇺🇸 Fort Worth, Texas, United States

Nephrology Associates, P.A.; 🇺🇸 Newark, Delaware, United States

Southwest Clinical Research Institute, LLC; 🇺🇸 Tempe, Arizona, United States

MakrisMD, LLC, d/b/a Chicago Access Care; 🇺🇸 Westmont, Illinois, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Providence Interventional Associates, LLC; 🇺🇸 Providence, Rhode Island, United States

Board of Regents of the University of Wisconsin System; 🇺🇸 Madison, Wisconsin, United States

The Board of Trustees of The University of Alabama for the University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Capital Nephrology Associates, P.A.; 🇺🇸 Raleigh, North Carolina, United States

Spartanburg Regional Health Services District, Inc.; 🇺🇸 Spartanburg, South Carolina, United States

San Antonio Kidney Disease Center Physicians Group, PLLC; 🇺🇸 San Antonio, Texas, United States

Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC; 🇺🇸 Phoenix, Arizona, United States

Capital Nephrology Medical Group; 🇺🇸 Sacramento, California, United States

RenalCare Associates, S.C. d/b/a Illinois Kidney Disease & Hypertension Center; 🇺🇸 Peoria, Illinois, United States

Massachusetts General Physicians Organizations, Inc.; 🇺🇸 Boston, Massachusetts, United States

Renal and Transplant Associates of New England, PC; 🇺🇸 Springfield, Massachusetts, United States

Oklahoma Life Access, PLLC; 🇺🇸 Tulsa, Oklahoma, United States

Trustees of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University Vascular Access; 🇺🇸 Memphis, Tennessee, United States