Using a drug-coated balloon to treat dysfunctional arteriovenous fistulae

A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

This study is testing a special drug-coated balloon to see if it can help people with problematic arteriovenous fistulae in their arms feel better and improve their blood flow.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 213 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: C. R. Bard (industry)
• Locations: 26 sites (Birmingham, Alabama and 25 other locations)
• Trial ID: NCT03506308 on ClinicalTrials.gov

What this trial studies

This global, multicenter study investigates the safety and clinical use of the Lutonix® 035 AV Drug Coated Balloon in patients with dysfunctional arteriovenous fistulae in the upper extremity. It is a post-market approval study mandated by the FDA to assess real-world outcomes and effectiveness of the device in a diverse patient population. Participants will undergo treatment with the Lutonix catheter, and their clinical and hemodynamic responses will be monitored over time.

Who should consider this trial

Good fit: Ideal candidates include adults with mature arteriovenous fistulae in the arm that exhibit clinical or hemodynamic abnormalities.

Not a fit: Patients with non-mature fistulae or those who do not meet the specific anatomical and clinical criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the functionality of arteriovenous fistulae, enhancing patient outcomes in dialysis and vascular access.

How similar studies have performed: Previous studies have shown promising results with drug-coated balloons in vascular interventions, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Male or non-pregnant, non-breastfeeding female ≥18 years of age
2. Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits
3. 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
4. Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
5. 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
6. Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:

   1. No clinically significant dissection;
   2. No extravasation requiring treatment;
   3. Residual stenosis ≤30% by angiographic measurement;
   4. Ability to completely efface the waist using the pre-dilation balloon.

Exclusion Criteria:

1. Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study
2. Subject has a non-controllable allergy to contrast
3. 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
4. Target lesion is located central to the axillosubclavian junction
5. A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure
6. Prior surgical interventions of the access site ≤30 days before the index procedure
7. Target lesion is located within a bare metal or covered stent

Where this trial is running

Birmingham, Alabama and 25 other locations

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

Study contacts

• Principal investigator: Scott Trerotola, MD — Hospital of the University of Pennsylvania; Division of Interventional Radiology
• Study coordinator: Bradley Forsyth, MBA

Conditions: Arteriovenous Fistula