Drug-Coated Balloon for Arteriovenous Fistula

(AVPAS Trial)

Recruiting at 24 trial locations

Overseen By Bradley Forsyth, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: C. R. Bard

Disqualifiers: Investigational study, Allergy to contrast, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate intervention

213 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and use of a new treatment called the Lutonix® 035 Drug Coated Balloon for individuals with issues in their arteriovenous (AV) fistulae in the arms. AV fistulae, connections between an artery and a vein often used for dialysis, can sometimes narrow or become blocked. The trial aims to determine if this drug-coated balloon can help keep these fistulae open and functioning well. Suitable participants have an AV fistula in their arm with noticeable issues, such as blockages, requiring imaging and treatment. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that the Lutonix® 035 AV Drug Coated Balloon is safe for use in arteriovenous fistulae?

Research has shown that the Lutonix® 035 AV Drug Coated Balloon is generally safe for patients. Studies have found it effective for treating blockages in arteriovenous (AV) fistulae, which are connections between an artery and a vein often used in dialysis. These studies did not identify any unexpected safety problems. The balloon releases a drug that helps keep the blood vessel open longer, and patients in previous trials experienced few side effects. Overall, the treatment is considered safe for its intended use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for maintaining arteriovenous fistulas, which often rely on mechanical interventions like standard balloon angioplasty, the Lutonix® 035 Drug Coated Balloon offers a unique approach. It combines the physical dilation of the vessel with the delivery of a drug, specifically paclitaxel, to the vessel wall. This dual action not only opens up the blood vessel but also releases the drug to help prevent re-narrowing over time. Researchers are excited because this could potentially reduce the need for repeated interventions, making it a more efficient and lasting solution for patients.

What evidence suggests that the Lutonix® 035 AV Drug Coated Balloon is effective for arteriovenous fistula?

Research shows that the Lutonix® 035 Drug Coated Balloon (DCB) effectively treats blockages in arteriovenous (AV) fistulae used for dialysis. Studies have found that this device keeps AV fistulae open longer than traditional methods. The balloon releases paclitaxel, a drug that prevents the vessel from narrowing again. One study showed that patients treated with the Lutonix DCB had better blood flow and required fewer repeat procedures compared to those who received standard treatment. These findings support the Lutonix DCB's effectiveness in maintaining AV fistula function. In this single-arm trial, all participants will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter. ^{1 2 5 6 7}

Who Is on the Research Team?

Dheeraj Rajan, MD

Principal Investigator

University Health Network; Division of Vascular & Interventional Radiology

Scott Trerotola, MD

Principal Investigator

Hospital of the University of Pennsylvania; Division of Interventional Radiology

Are You a Good Fit for This Trial?

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.

Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lutonix® 035 AV Drug Coated Balloon

Trial Overview 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.

How Is the Trial Designed?

Group I: LUTONIX 035 Drug Coated Balloon PTA Catheter Experimental Treatment 1 Intervention

This is a single-arm study. All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Lutonix® 035 AV Drug Coated Balloon is already approved in United States for the following indications:

Approved in United States as Lutonix DCB for:

• Percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm.

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

Published Research Related to This Trial

The Lutonix drug-coated balloon (DCB) catheter demonstrated a high safety profile with a 95.5% freedom from serious adverse events in a study involving 320 subjects across 25 sites in Europe and Asia.

The treatment showed a target lesion primary patency (TLPP) of 73.9% at 6 months, indicating its effectiveness in maintaining blood flow in dysfunctional arteriovenous fistulae and grafts, especially when procedural techniques like predilation were used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results. Karnabatidis, D., Kitrou, PM., Ponce, P., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Center Experience With Lutonix Drug-Coated Balloons in Infrapopliteal Arteries. Steiner, S., Schmidt, A., Bausback, Y., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon. Escárcega, RO., Waksman, R.[2014]

The Lutonix drug-coated balloon (DCB) significantly reduced late lumen loss by 58% compared to uncoated balloons at 6 months, indicating its efficacy in treating femoropopliteal lesions.

The safety profile of the Lutonix DCB was comparable to that of uncoated balloons, with a lower rate of major adverse events (39% vs. 46%) over 24 months, suggesting it is a safe option for patients with peripheral vascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Scheinert, D., Duda, S., Zeller, T., et al.[2022]

The lutonix paclitaxel-coated balloon (PCB) demonstrated a target lesion primary patency (TLPP) of 72.2% at 6 months in a study of 39 patients, indicating its effectiveness in treating dysfunctional dialysis access.

No major complications were reported during the study, highlighting the safety of the PCB treatment, and a significant improvement in patency was observed after a second PCB intervention compared to the first.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel-Coated Balloons for the Treatment of Dysfunctional Dialysis Access. Results from a Single-Center, Retrospective Analysis. Kitrou, PM., Spiliopoulos, S., Papadimatos, P., et al.[2022]

In a study involving 1,093 patients treated with femoropopliteal drug-coated balloon (DCB) angioplasty, there were no significant differences in mortality rates compared to those who underwent uncoated balloon angioplasty (PTA), suggesting that DCB angioplasty is a safe option.

The analysis found no evidence of a causal relationship between paclitaxel-coated devices and increased mortality, as there were no clustering of causes of death or dose-response relationships identified in the patient-level data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. Ouriel, K., Adelman, MA., Rosenfield, K., et al.[2020]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170003B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The LUTONIX. ®. 035 Drug Coated Balloon PTA Catheter (LUTONIX. ®. 035 DCB) is an over-the-wire drug coated percutaneous angioplasty catheter with a paclitaxel- ...

2. evtoday.com evtoday.com/articles/2019-oct-supplement/the-use-of-the-lutonix-035-drug-coated-balloon-pta-catheter-for-challenging-av-access-stenosis

The Use of the LUTONIX® 035 Drug Coated Balloon PTA ... Clinical studies have demonstrated outcome benefit when DCBs are used to treat stenosis occurring in AV access.1 The recently completed Lutonix AV clinical ...

3. valueinhealthjournal.com valueinhealthjournal.com/article/S1098-3015(17)31342-6/fulltext

Economic Analysis Of The Lutonix® 035 Drug Coated ... A recent randomized controlled trial evaluated the safety and efficacy of the LUTONIX® 035 Drug Coated Balloon PTA catheter (DCB) versus PTA for the treatment ...

4. bd.com bd.com/en-us/products-and-solutions/products/product-families/lutonix-035-dcb-dysfunctional-av-fistula-indication

Lutonix™ 035 DCB – Dysfunctional AV Fistula Indication The safety and effectiveness of the Lutonix™ Catheter have not been established for treatment in cerebral, carotid, coronary, or renal vasculature. • The safety ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2212109922001170

Cost-Effectiveness of Drug-Coated Balloon Angioplasty ... This study aimed to determine the cost-effectiveness of drug-coated balloon (DCB) angioplasty compared with conventional balloon angioplasty (cPTA)

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170003A.pdf

Lutonix - accessdata.fda.gov This study will evaluate the long-term safety and effectiveness of the. Lutonix 035AV Drug Coated Balloon Catheter (Lutonix 035 DCB) in the remaining 265.

7. bd.com bd.com/content/dam/bd-assets/na/peripheral-intervention/web-assets/us/documents/bd-135000-lutonixav-fistulacohort-brochure.pdf

Lutonix AV Global Registry The Lutonix AV Global Registry was a prospective, multi-center, single-arm, real-world registry that assessed the safety and effectiveness of Lutonix™ 035 ...