Drug-Coated Balloon for Arteriovenous Fistula

(AVPAS Trial)

Recruiting at 22 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

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. ^{1 2 3 4 5}

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. ^{2 3 5 6 7}

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. ^{2 3 4 5 6}

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

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.

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

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

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.

Participant Groups

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

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.

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]

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]

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) 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Single-Center Experience With Lutonix Drug-Coated Balloons in Infrapopliteal Arteries. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Paclitaxel drug-coated balloon angioplasty for the treatment of failing arteriovenous fistulas: a single-center experience. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results. [2021]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel-Coated Balloons for the Treatment of Dysfunctional Dialysis Access. Results from a Single-Center, Retrospective Analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. [2020]