Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

Running, not enrolling · Not applicable

Conditions studied: Arteriovenous Fistula

In brief

This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Key facts

Study ID

NCT03506308

Run by

C. R. Bard

People needed

213

Starts

2018-08-07

Expected to finish

2030-04-01

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or non-pregnant, non-breastfeeding female ≥18 years of age
• Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits
• Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines
• Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
• Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein
• Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:
• No clinically significant dissection;
• No extravasation requiring treatment;
• Residual stenosis ≤30% by angiographic measurement;
• Ability to completely efface the waist using the pre-dilation balloon.

You may not qualify if…

• Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study
• Subject has a non-controllable allergy to contrast
• Subject has another medical condition that, in the opinion of the Investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up
• Target lesion is located central to the axillosubclavian junction
• A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure
• Prior surgical interventions of the access site ≤30 days before the index procedure
• Target lesion is located within a bare metal or covered stent

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Flowers Hospital — Dothan, Alabama, United States
• St. Joseph Hospital of Orange — Orange, California, United States
• Kaiser Permanente — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• Ochsner Health System — New Orleans, Louisiana, United States
• Ochsner Louisiana State University Health — Shreveport, Louisiana, United States
• MedStar Health Research Institute — Annapolis, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Rochester General Hospital — Rochester, New York, United States
• Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Dallas Vascular Center — Dallas, Texas, United States
• HCA Houston Healthcare — Houston, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• University of Texas Health Science Center — Houston, Texas, United States
• Sentara Medical Group — Norfolk, Virginia, United States
• William Osler Health System/Brampton Civic Hospital — Brampton, Ontario, Canada
• Scarborough Health Network — Scarborough Village, Ontario, Canada
• University Health Network — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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