Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae
NCT ID: NCT02440022
Last Updated: 2020-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
285 participants
INTERVENTIONAL
2015-06-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lutonix DCB
Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.
Lutonix DCB
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.
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 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.
Interventions
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Lutonix DCB
Standard Balloon Angioplasty Catheter
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Trerotola, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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The Board of Trustees of The University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC
Phoenix, Arizona, United States
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States
Capital Nephrology Medical Group
Sacramento, California, United States
Nephrology Associates, P.A.
Newark, Delaware, United States
Rush University
Chicago, Illinois, United States
RenalCare Associates, S.C. d/b/a Illinois Kidney Disease & Hypertension Center
Peoria, Illinois, United States
MakrisMD, LLC, d/b/a Chicago Access Care
Westmont, Illinois, United States
Massachusetts General Physicians Organizations, Inc.
Boston, Massachusetts, United States
Renal and Transplant Associates of New England, PC
Springfield, Massachusetts, United States
Michigan Vascular Center
Flint, Michigan, United States
Minnesota Vascular Surgery Center
New Brighton, Minnesota, United States
Capital Nephrology Associates, P.A.
Raleigh, North Carolina, United States
Oklahoma Life Access, PLLC
Tulsa, Oklahoma, United States
Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Providence Interventional Associates, LLC
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Spartanburg Regional Health Services District, Inc.
Spartanburg, South Carolina, United States
University Vascular Access
Memphis, Tennessee, United States
Tarrant Vascular Clinic
Fort Worth, Texas, United States
San Antonio Kidney Disease Center Physicians Group, PLLC
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Board of Regents of the University of Wisconsin System
Madison, Wisconsin, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CL0023-01
Identifier Type: -
Identifier Source: org_study_id
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