What side effects are associated with this type of intervention?

The most common treatments for arteriovenous fistulae, particularly those involving drug-coated balloons like the Lutonix® 035 AV DCB, can have several side effects. These may include local site reactions such as pain, swelling, and bruising. There is also a risk of infection at the catheter insertion site. Specific to drug-coated balloons, potential side effects include allergic reactions to the drug coating, thrombosis, and restenosis despite treatment. Additionally, systemic side effects from the drug, such as paclitaxel, may include nausea, vomiting, and in rare cases, more severe reactions like hypersensitivity or cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at improving the patency and function of arteriovenous (AV) fistulae, particularly focusing on drug-coated balloons (DCBs). One notable example is the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter, which is designed to prevent restenosis and maintain the patency of AV fistulae. This device uses a paclitaxel coating to inhibit neointimal hyperplasia, a common cause of restenosis. Other similar FDA-approved DCBs include the IN.PACT™ AV DCB, which also utilizes paclitaxel to achieve similar outcomes in maintaining AV fistula function.

What other types of research exist?

Promising alternatives to the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter for AV fistula patients include: 1) The IN.PACT™ AV DCB, which has shown positive results in reducing restenosis and maintaining AVF patency. 2) The SeQuent® Please NEO DCB, which is being investigated for its efficacy in AVF interventions. 3) The Covera™ Vascular Covered Stent, designed to provide mechanical support and prevent restenosis in AVFs. These alternatives are supported by recent clinical trials and studies demonstrating their potential benefits in AVF management.

← Back to Search

Drug Coated Balloon

Drug-Coated Balloon for Arteriovenous Fistula (AVPAS Trial)

N/A

Recruiting

Led By Scott Trerotola, MD

Research Sponsored by C. R. Bard

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, 18, 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects may include reactions related to balloon angioplasty such as pain at the access site, bleeding or bruising, blood vessel damage, infection risk at the catheter insertion point and potential allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My arm's blood vessel connection needs imaging due to issues.

Select...

My lesion can be treated with a specific device according to its usage guide.

Select...

I am an adult over 18 and not pregnant or breastfeeding.

Select...

My AV fistula has a narrowing in the vein from where it's connected to near my shoulder.

Select...

My artery was successfully widened without major issues using a special balloon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My target lesion is near the center of my shoulder area.

Select...

I had a clot in my dialysis access treated within the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12, 18, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 12, 18, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 18, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With No Primary Safety Events

Percentage of Participants With Target Lesion Primary Patency (TLPP)

Secondary study objectives

Number of re-interventions required to maintain access circuit patency

Number of re-interventions required to maintain target lesion patency

Percentage of Participants With Abandonment of Permanent Access in the Index Extremity

+7 more

Other study objectives

Vital status of participants

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for arteriovenous fistulae (AVF) include percutaneous transluminal angioplasty (PTA) and the use of drug-coated balloons (DCBs). PTA mechanically dilates the vessel to improve blood flow, while DCBs, such as the Lutonix® 035 AV DCB, release antiproliferative drugs like paclitaxel to prevent restenosis by inhibiting smooth muscle cell proliferation. This is crucial for AVF patients as it helps maintain the patency of the fistula, ensuring effective dialysis access and reducing the need for repeat interventions.

The guglielmi detachable coil in the treatment of arteriovenous fistulae.