Clinical trial NCT02440022: Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arteriovenous Fistula
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 285
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure
timeFrame: 6 months post index procedure
measure: Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.
timeFrame: 30 Days Post Index Procedure
Secondary outcomes:
measure: Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months
timeFrame: 3, 9, 12, 18, and 24 Months Post Index Procedure
measure: Percentage of Participants With Device, Procedural and Clinical Success
timeFrame: Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure
measure: Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
timeFrame: 3, 6, 9, 12, 18 and 24 Months Post Index Procedure
measure: Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
timeFrame: 3, 6, 9, 12, 18 and 24 Months Post Index Procedure
measure: Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated)
timeFrame: 1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure
measure: Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure
timeFrame: 6 Months Post Index Procedure
measure: Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
timeFrame: 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
measure: Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
timeFrame: 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Board of Trustees of The University of Alabama for the University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC
state: Arizona
city: Tempe
country: United States
facility: Southwest Clinical Research Institute, LLC
state: Arizona
city: Sacramento
country: United States
facility: Capital Nephrology Medical Group
state: California
city: Newark
country: United States
facility: Nephrology Associates, P.A.
state: Delaware
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Peoria
country: United States
facility: RenalCare Associates, S.C. d/b/a Illinois Kidney Disease & Hypertension Center
state: Illinois
city: Westmont
country: United States
facility: MakrisMD, LLC, d/b/a Chicago Access Care
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Physicians Organizations, Inc.
state: Massachusetts
city: Springfield
country: United States
facility: Renal and Transplant Associates of New England, PC
state: Massachusetts
city: Flint
country: United States
facility: Michigan Vascular Center
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Vascular Surgery Center
state: Minnesota
city: Raleigh
country: United States
facility: Capital Nephrology Associates, P.A.
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Life Access, PLLC
state: Oklahoma
city: Philadelphia
country: United States
facility: Trustees of the University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Providence Interventional Associates, LLC
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Health Services District, Inc.
state: South Carolina
city: Memphis
country: United States
facility: University Vascular Access
state: Tennessee
city: Fort Worth
country: United States
facility: Tarrant Vascular Clinic
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney Disease Center Physicians Group, PLLC
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Madison
country: United States
facility: Board of Regents of the University of Wisconsin System
state: Wisconsin
Study officials:
affiliation: University of Pennsylvania
name: Scott Trerotola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.