Auryon Atherectomy + Balloon Angioplasty for Peripheral Artery Disease

(AMBITION BTK Trial)

Recruiting at 7 trial locations

Overseen By Liz Manning

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Angiodynamics, Inc.

Must not be taking: Antiplatelets, Anticoagulants, Thrombolytics, others

Disqualifiers: Pregnancy, Renal disease, Myocardial infarction, Stroke, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining the Auryon Atherectomy System with balloon angioplasty is more effective than balloon angioplasty alone for treating blockages in the lower leg arteries. Researchers aim to determine if this treatment can better prevent serious issues such as death, the need for amputation, and artery re-blockage. Suitable candidates for this trial include individuals with significant lower limb artery blockages who experience symptoms like pain when walking (claudication) or more severe issues like critical limb ischemia. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on antiplatelet or anticoagulant therapy, you may need to discuss this with the trial team, as the protocol mentions that these therapies should not be contraindicated.

What is the safety track record for the Auryon Atherectomy System and balloon angioplasty?

Research has shown that the Auryon Atherectomy System is generally safe for treating peripheral artery disease (PAD). Studies have found no major complications or deaths linked to the procedure. In one study involving 107 treated areas, the arteries remained open after treatment, with no blockages. Another review of real-world cases also reported no issues or deaths during the procedure. These findings suggest that patients generally tolerate the treatment well. While more information is always useful, current evidence supports the safety of the Auryon System for managing blockages in the legs. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Auryon Atherectomy System combined with balloon angioplasty because it offers a novel approach to treating Peripheral Artery Disease (PAD). Unlike standard treatments that typically rely on balloon angioplasty alone, the Auryon system uses laser technology to precisely remove plaque build-up in the arteries before the angioplasty. This dual-action method not only aims to improve blood flow more effectively but also potentially reduces the risk of artery re-narrowing, which is a common issue with traditional methods. The combination of these two techniques could lead to better long-term outcomes for patients with PAD.

What evidence suggests that the Auryon Atherectomy System with balloon angioplasty is effective for treating peripheral artery disease?

Research has shown that the Auryon Atherectomy System is safe and effective for treating peripheral artery disease (PAD). Studies have found it effective in various PAD cases, with no major side effects reported. This trial will compare two treatment approaches: one group will receive the Auryon Atherectomy System followed by Balloon Angioplasty, while another group will receive Balloon Angioplasty only. The Auryon system can address blockages both above and below the knee, improving blood flow and reducing the risk of amputation. In everyday use, patients treated with the Auryon system experienced fewer problems and better outcomes. Overall, this system has shown promise in improving the health of people with blockages in their lower limbs. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with blockages in the arteries of their lower limbs, specifically below the knee to above the ankle. Participants must have a life expectancy of at least one year and be able to follow study procedures. Only those with a single lesion and moderate-to-severe limb symptoms can join.

Inclusion Criteria

My doctor expects me to live for at least another year.

I am willing and able to follow all study requirements.

I understand the study and have signed the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects will be treated with the Auryon Atherectomy System followed by Percutaneous Balloon Angioplasty or with percutaneous balloon angioplasty only

Up to 12 months

Multiple visits as required for procedures

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 30 days, and 6, 12, 24 months

24 months

Regular follow-up visits at specified intervals

What Are the Treatments Tested in This Trial?

Interventions

• Auryon Atherectomy System
• Balloon Angioplasty

Trial Overview Researchers are testing if using the Auryon Atherectomy System along with balloon angioplasty is more effective than just balloon angioplasty in preventing death, amputation, or need for revascularization while improving artery openness.

How Is the Trial Designed?

Group I: Auryon Atherectomy System and Balloon Angioplasty Experimental Treatment 1 Intervention

Subjects will be treated with the Auryon Atherectomy System followed by Percutaneous Balloon Angioplasty

Group II: Balloon Angioplasty Only Active Control 1 Intervention

Subjects assigned to this treatment group will be treated with percutaneous balloon angioplasty only.

Who Is Running the Clinical Trial?

Angiodynamics, Inc.

Lead Sponsor

Trials

27

Recruited

3,100+

Published Research Related to This Trial

In a study of 120 patients with severe lower extremity peripheral arterial disease, directional atherectomy using the Phoenix system achieved a high overall technical success rate of 97.7% and a clinical success rate of 98.2%.

The procedure showed a low incidence of major adverse events (5% for SFA and 7.7% for popliteal) and a high rate of improvement in Rutherford classification scores, indicating its efficacy and safety in treating occluded arteries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid atherectomy for lower extremity peripheral arterial disease. Turkyilmaz, S., Kavala, AA.[2019]

The Phoenix Atherectomy™ System demonstrated a high technical success rate, achieving primary technical success in 51 out of 52 patients with heavily calcified femoro-popliteal lesions.

The system showed excellent primary vessel patency rates at 1, 6, and 12 months, with rates of 96.1%, 86.5%, and 76.9% respectively, indicating its efficacy in maintaining blood flow after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single-Center Experience With Phoenix Atherectomy System in Patients With Moderate to Heavily Calcified Femoropopliteal Lesions. Gandini, R., Pratesi, G., Merolla, S., et al.[2020]

The Pathway PV System demonstrated a high device success rate of 99% in treating 210 infrainguinal arterial lesions, with a low major adverse event rate of only 1% at 30 days, indicating its safety for patients.

Significant improvements were observed in ankle-brachial index and Rutherford class after 12 months, suggesting that the system effectively enhances blood flow and reduces symptoms of lower limb ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. Zeller, T., Krankenberg, H., Steinkamp, H., et al.[2022]

The Phoenix atherectomy system demonstrated high procedural success rates of 97.3% for non-CLI patients and 98.2% for CLI patients, with a low complication rate of less than 1% after treatment in a study of 500 patients with peripheral artery disease (PAD).

Despite some minor amputations (6.8% in the CLI cohort), there were no major amputations, indicating that the Phoenix system is a safe and effective option for treating PAD, even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Real-World Outcomes From the Phoenix Post-Approval Registry. Shishehbor, MH., Griffin, J., Crowder, W., et al.[2022]

The Revolution Peripheral Atherectomy System demonstrated a high technical success rate of 90.2% in treating 148 lesions in patients with peripheral arterial disease, significantly reducing stenosis from an average of 73% to 42%.

The procedure had a low complication rate, with only 3.1% of patients experiencing major adverse events, and showed promising patency rates at 6 months, with 81.6% primary patency, indicating its effectiveness and safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

United States Investigational Device Exemption study of the Revolution Peripheral Atherectomy System. Carr, J., Bowman, J., Watts, M., et al.[2022]

Citations

1. auryon-system.com auryon-system.com/trial-data/

Trial Data | The Auryon System for PAD The Auryon System demonstrated clinically proven performance in a broad range of disease severity. Individual results may vary.

2. sciencedirect.com sciencedirect.com/science/article/pii/S155383892300667X

Trends in outcomes associated with the use of Auryon ... The Auryon laser system was shown to be safe and effective in this real-world patient population with no procedural adverse events or deaths and improvements ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37393189/

Trends in outcomes associated with the use of Auryon ... Conclusion: The Auryon laser system was shown to be safe and effective in this real-world patient population with no procedural adverse events ...

4. asrjs.com asrjs.com/pdfs/outcomes-associated-with-the-use-of-the-auryon-peripheral-atherectomy-system-in-a-hospital-setting-1year-outcome-174.pdf

outcomes-associated-with-the-use-of-the-auryon- ... The present study illustrates twelve real cases in a single hospital evaluating the safety and efficacy of the Auryon atherectomy system in patients with PAD.

5. evtoday.com evtoday.com/articles/2020-nov/case-reports-the-auryon-atherectomy-system-above-and-below-the-knee

Case Reports: The Auryon Atherectomy System Above and ... The Auryon atherectomy system appears to be a safe and effective treatment above and below the knee, including for critical limb ischemia.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04229563

Post-Market Registry of AURYON™ Atherectomy Device in ... A pilot registry towards a subsequent large pivotal registry (PATHFINDER II), aimed to evaluate the safety and efficacy of Auryon™ Atherectomy System in the ...