~10 spots leftby Sep 2025

Drug-Coated Balloon for Arteriovenous Fistula

(AVPAS Trial)

Recruiting at 22 trial locations
KS
AL
BF
Overseen ByBradley Forsyth, MBA
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: C. R. Bard
Disqualifiers: Investigational study, Allergy to contrast, others
No Placebo Group
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial investigates a special balloon coated with medication to help open and keep open blood vessels in the arms of patients with problematic AV fistulae, which are crucial for dialysis. The Selution Sustained Limus Release (SLR) sirolimus-coated balloon is being tested for improving the patency of failing arteriovenous fistulas (AVF) in hemodialysis patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the Lutonix drug-coated balloon treatment for arteriovenous fistula?

The Lutonix drug-coated balloon has shown a short-term benefit in keeping arteriovenous fistulas open, with a 69.2% success rate at 6 months and 31.6% at 12 months, compared to traditional balloon treatments.12345

Is the Lutonix drug-coated balloon generally safe for use in humans?

The Lutonix drug-coated balloon has been evaluated in several studies, including for arteriovenous fistulas and femoropopliteal artery disease. In these studies, it showed no major or minor complications, indicating it is generally safe for use in humans.23567

How is the Lutonix drug-coated balloon treatment different for arteriovenous fistula?

The Lutonix drug-coated balloon is unique because it combines a standard balloon used in angioplasty with a coating of paclitaxel, a drug that helps keep blood vessels open longer. This treatment aims to improve the patency (openness) of arteriovenous fistulas, which are used for dialysis, by reducing the chance of them narrowing again compared to traditional balloon treatments.23456

Research Team

DR

Dheeraj Rajan, MD

Principal Investigator

University Health Network; Division of Vascular & Interventional Radiology

ST

Scott Trerotola, MD

Principal Investigator

Hospital of the University of Pennsylvania; Division of Interventional Radiology

Eligibility Criteria

This trial is for adults over 18 with a mature arteriovenous fistula in the arm that needs treatment based on specific guidelines. Participants must be able to give informed consent and follow the study's visit schedule. They can't join if they have other conditions affecting data or life expectancy, recent surgeries at the site, stents in place, are in another study, have severe contrast allergies, or had a thrombosis treated recently.

Inclusion Criteria

My arm's blood vessel connection needs imaging due to issues.
My lesion can be treated with a specific device according to its usage guide.
I am an adult over 18 and not pregnant or breastfeeding.
See 3 more

Exclusion Criteria

I haven't had surgery at the procedure site in the last 30 days.
You have an allergy to contrast dye that cannot be controlled.
My target lesion is near the center of my shoulder area.
See 4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Lutonix® 035 Drug Coated Balloon PTA Catheter for the treatment of dysfunctional AV fistulae

Immediate intervention
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patency and adverse events

6, 12, 18, 24 months
Multiple visits (in-person and virtual)

Long-term Follow-up

Participants' vital status and long-term outcomes are assessed

36, 48, 60 months

Treatment Details

Interventions

  • Lutonix® 035 AV Drug Coated Balloon (Drug Coated Balloon)
Trial OverviewThe Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter is being tested for safety and effectiveness in treating dysfunctional arteriovenous fistulas located in the upper extremity. This global study involves one group of participants who will all receive this particular treatment following successful pre-dilation of their lesion.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: LUTONIX 035 Drug Coated Balloon PTA CatheterExperimental Treatment1 Intervention
This is a single-arm study. All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Find a Clinic Near You

Who Is Running the Clinical Trial?

C. R. Bard

Lead Sponsor

Trials
109
Recruited
40,200+

Timothy M. Ring

C. R. Bard

Chief Executive Officer since 2003

Bachelor of Science in Industrial and Labor Relations from Cornell University

Dr. Cimler

C. R. Bard

Chief Medical Officer since 2017

Ph.D. in Pharmacology

Findings from Research

In a study of 208 patients with severe claudication or critical limb ischemia treated with the Lutonix drug-coated balloon, 59.1% of limbs showed improvement in symptoms after one year, indicating its efficacy in treating peripheral artery disease.
The Lutonix DCB demonstrated a low rate of major amputations (4.1%) and a high freedom from death or major amputation (92% at 6 months), suggesting it is a safe option for patients with significant vascular issues.
Single-Center Experience With Lutonix Drug-Coated Balloons in Infrapopliteal Arteries.Steiner, S., Schmidt, A., Bausback, Y., et al.[2022]
The Lutonix® drug coated balloon (DCB) is designed to improve blood flow in patients with atherosclerotic disease in the femoropopliteal region by delivering paclitaxel, a drug that helps prevent artery re-narrowing after treatment.
The FDA's advisory panel reviewed the DCB's premarket approval application based on a pivotal clinical trial comparing it to standard angioplasty, indicating strong support for its potential approval due to its promising efficacy in improving patency rates.
Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon.Escárcega, RO., Waksman, R.[2014]
In a study of 14 patients treated with Lutonix drug-coated balloons for failing arteriovenous fistulas, the procedure achieved a technical success rate of 100% and a clinical success rate of 92.9%, with no complications reported.
The use of Lutonix DCBs resulted in better short-term primary patency rates for the target lesions and dialysis circuits compared to traditional balloon angioplasty, with 69.2% and 61.5% patency at 6 months, respectively.
Paclitaxel drug-coated balloon angioplasty for the treatment of failing arteriovenous fistulas: a single-center experience.Yazar, O., Provoost, A., Broughton, A., et al.[2021]

References

Single-Center Experience With Lutonix Drug-Coated Balloons in Infrapopliteal Arteries. [2022]
Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon. [2014]
Paclitaxel drug-coated balloon angioplasty for the treatment of failing arteriovenous fistulas: a single-center experience. [2021]
A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results. [2021]
The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. [2022]
Paclitaxel-Coated Balloons for the Treatment of Dysfunctional Dialysis Access. Results from a Single-Center, Retrospective Analysis. [2022]
Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. [2020]