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

Completed · Phase 3

Conditions studied: Arteriovenous Fistula

In brief

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.

Key facts

Study ID

NCT02440022

Run by

C. R. Bard

People needed

285

Starts

2015-06-01

Expected to finish

2018-06-01

Last updated by the study team

2020-05-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Women who are pregnant, lactating, or planning on becoming pregnant during the study;
• Hemodialysis access is located in the leg;
• Subject has more than two lesions in the access circuit;
• Subject has a secondary non-target lesion that cannot be successfully treated;
• Target lesion is located central to the axillosubclavian junction;
• The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction);
• A thrombosed access;
• Surgical revision of the access site planned;
• Recent prior surgical interventions of the access site;
• Other planned treatment during the index procedure;
• Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication;
• Known contraindication (including allergic reaction) or sensitivity to paclitaxel.
• Subjects who are taking immunosuppressive therapy or are routinely taking
• ≥10mg of prednisone per day;
• 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;
• Subject has a life expectancy <12 months;
• Anticipated for a kidney transplant;
• Anticipated conversion to peritoneal dialysis;
• Subject has a stent located in the target or secondary non target lesion;
• Subject has an infected AV access or systemic infection;
• Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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