Auryon Atherectomy + Balloon Angioplasty for Peripheral Artery Disease

(AMBITION BTK Trial)

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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the Auryon Atherectomy System and Balloon Angioplasty treatment for Peripheral Artery Disease?

Research on similar atherectomy systems, like the Phoenix and Revolution systems, shows they can be effective in treating peripheral artery disease by removing blockages in blood vessels. These studies suggest that using atherectomy systems can help improve blood flow in patients with blocked arteries in the legs. ^{1 2 3 4 5}

Is the Auryon Atherectomy + Balloon Angioplasty treatment safe for humans?

Studies on similar atherectomy systems show that the procedure is generally safe, with some risks like distal embolization (blockage caused by debris) and arterial perforation (tear in the artery). Major complications are infrequent, and the procedure is considered feasible and predictable for treating peripheral artery disease. ^{2 3 5 6 7}

How is the Auryon Atherectomy System treatment different from other treatments for peripheral artery disease?

The Auryon Atherectomy System is unique because it combines atherectomy (removal of plaque from arteries) with balloon angioplasty (widening of narrowed arteries) to treat peripheral artery disease, potentially reducing risks like distal embolization (blockage caused by debris) and arterial perforation (tearing). This combination aims to improve the safety and effectiveness of treating blockages in leg arteries compared to using these methods separately. ^{1 2 4 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Hybrid atherectomy for lower extremity peripheral arterial disease. [2019]

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

United States Investigational Device Exemption study of the Revolution Peripheral Atherectomy System. [2022]

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

A Single-Center Experience With Phoenix Atherectomy System in Patients With Moderate to Heavily Calcified Femoropopliteal Lesions. [2020]

4. United States 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. [2022]

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

Atherectomy of heavily calcified femoropopliteal stenotic lesions. [2016]

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

Acute Real-World Outcomes From the Phoenix Post-Approval Registry. [2022]

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

Directional atherectomy. New approaches for treatment of obstructive coronary and peripheral vascular disease. [2016]

8. Germany pubmed.ncbi.nlm.nih.gov

[Peripheral Simpson atherectomy. Indications and results of a new transluminal procedure for vascular recanalization]. [2006]

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

Alternatives for revascularization: peripheral atherectomy devices. [2004]