Pulse IVL for Peripheral Arterial Disease

(POWER PAD 2 Trial)

Recruiting at 15 trial locations

Overseen By Elizabeth Galle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Amplitude Vascular Systems, Inc.

Must not be taking: Antiplatelets, Anticoagulants, Thrombolytics

Disqualifiers: Infection, Amputation, Stroke, Renal disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Day of procedure

120 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, you cannot participate if you are contraindicated for antiplatelet, anticoagulant, or thrombolytic therapy, or if you have a known allergy to medications used in the procedure.

What data supports the effectiveness of the treatment Pulse Intravascular Lithotripsy (Pulse IVL) for Peripheral Arterial Disease?

Research shows that Intravascular Lithotripsy (IVL) is effective in treating peripheral arterial disease by using sound waves to break up hard calcium deposits in the arteries, which helps improve blood flow. Studies have demonstrated that IVL can safely and effectively modify calcified plaques, making it easier to expand the blood vessels and improve circulation. ^{1 2 3 4 5}

How is Pulse Intravascular Lithotripsy (Pulse IVL) different from other treatments for peripheral arterial disease?

Pulse Intravascular Lithotripsy (Pulse IVL) is unique because it uses acoustic shockwaves to break up hard, calcified plaques in the arteries, allowing for better blood flow. This method is different from traditional treatments as it can modify these tough plaques without needing high-pressure balloons, potentially reducing the risk of artery damage. ^{1 2 3 4 6}

What is the purpose of this trial?

POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular Systems (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™) System for treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.

Research Team

Christopher Metzger, MD

Principal Investigator

Ohio Health

Eligibility Criteria

This trial is for adults over 18 with Peripheral Arterial Disease, specifically those with a low ankle-brachial index or significant artery narrowing confirmed by imaging. Participants should be experiencing certain symptoms and must be expected to live at least another year. They need to agree to the study's procedures and sign consent.

Inclusion Criteria

I meet the basic requirements to participate in the study.

My condition requires or has required an angiogram.

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

Participants receive Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls

Day of procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person) at discharge, 30 days, and 6 months

Treatment Details

Interventions

• Pulse Intravascular Lithotripsy (Pulse IVL)

Trial Overview The POWER PAD 2 trial is testing the safety and effectiveness of Pulse Intravascular Lithotripsy (Pulse IVL) in treating calcified blockages in leg arteries. This single-arm study involves patients receiving this treatment without being compared to another group.

Participant Groups

Group I: Pulse Intravascular Lithotripsy™ (Pulse IVL™) Experimental Treatment 1 Intervention

Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls

Pulse Intravascular Lithotripsy (Pulse IVL) is already approved in European Union, United States for the following indications:

Approved in European Union as Pulse IVL for:

• Peripheral arterial disease
• Calcified stenotic lesions in superficial femoral and popliteal arteries

Approved in United States as Pulse IVL for:

• Peripheral arterial disease
• Calcified stenotic lesions in superficial femoral and popliteal arteries

Who Is Running the Clinical Trial?

Amplitude Vascular Systems, Inc.

Lead Sponsor

Trials

2

Recruited

130+

Findings from Research

The Peripheral Intravascular Lithotripsy (IVL) System effectively disrupts calcified lesions in arteries, making it a promising tool for improving access in procedures like EVAR and TAVR, as well as treating peripheral arterial disease.

Using IVL allows for angioplasty at lower pressures, which may reduce the risk of arterial dissection and improve vessel compliance, enhancing overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Epidemiology, Pathophysiology, and Novel Treatment of Calcific Arterial Disease. Price, LZ., Faries, PL., McKinsey, JF., et al.[2019]

In a study involving 16 mini-pigs, intravascular lithotripsy (IVL) was found to have a comparable safety profile to plain old balloon angioplasty (POBA), with no significant differences in vascular damage or endothelial cell integrity observed at various time points.

While IVL did not cause serious tissue damage, it resulted in a trend toward increased neointimal thickening and inflammation compared to POBA, suggesting that while IVL is safe, its long-term effects on arterial healing may require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injury and Healing Response of Healthy Peripheral Arterial Tissue to Intravascular Lithotripsy: A Prospective Animal Study. Liu, F., Ge, Y., Rong, D., et al.[2022]

Intravascular lithotripsy (IVL) is an effective technique for modifying calcified plaques in patients with peripheral artery disease (PAD), achieving a significant reduction in diameter stenosis of 59.3% based on a meta-analysis of 681 patients across nine studies.

The procedure is associated with a low rate of vascular complications (only 1.25%) and a stent placement rate of 15.89%, indicating that IVL is a safe option for treating severely calcified lesions in lower extremities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Intravascular Lithotripsy in Lower Extremity Peripheral Artery Disease: A Systematic Review and Meta-Analysis. Wong, CP., Chan, LP., Au, DM., et al.[2022]

Intravascular lithotripsy (IVL) is an innovative technique that uses acoustic shockwaves to break apart severely calcified plaques in blood vessels, which helps improve blood flow and vessel expansion.

The review highlights the effectiveness of IVL in various peripheral vascular treatments, including its role in facilitating access for larger medical devices, showcasing its potential for broader clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acoustic Shock Waves to Modify Calcific Plaques - Intravascular Lithotripsy in the Peripheral Circulation. Karimi Galougahi, K., Soukas, PA., Kolski, B., et al.[2022]

In a pooled analysis of 336 patients with peripheral arterial disease (PAD) treated with intravascular lithotripsy (IVL), there was a significant reduction in the percent diameter stenosis (narrowing of the artery) by 55.1%, indicating the efficacy of IVL in treating calcified lesions.

The procedure demonstrated a high safety profile, with only 1.22% of treated lesions experiencing serious complications, such as vessel perforation or flow-limiting dissections, suggesting that IVL is a safe option for patients with extensive arterial calcification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: An individual patient-level pooled data analysis. Madhavan, MV., Shahim, B., Mena-Hurtado, C., et al.[2021]

Intravascular lithotripsy (IVL) has been successfully used in 60 patients with severe calcification in various non-coronary arteries, including the iliofemoral and carotid arteries, demonstrating its efficacy in plaque modification and revascularization.

While IVL showed a 12% complication rate, primarily involving dissections, the technique was generally effective and safe for treating challenging vascular lesions, particularly in older patients with a mean age of 73.7 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of intravascular lithotripsy in non-coronary artery lesions. Umeh, CA., Stratton, A., Wagner, T., et al.[2023]

References

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

The Epidemiology, Pathophysiology, and Novel Treatment of Calcific Arterial Disease. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Injury and Healing Response of Healthy Peripheral Arterial Tissue to Intravascular Lithotripsy: A Prospective Animal Study. [2022]

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

Efficacy and Safety of Intravascular Lithotripsy in Lower Extremity Peripheral Artery Disease: A Systematic Review and Meta-Analysis. [2022]

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

Acoustic Shock Waves to Modify Calcific Plaques - Intravascular Lithotripsy in the Peripheral Circulation. [2022]

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

Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: An individual patient-level pooled data analysis. [2021]

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

Use of intravascular lithotripsy in non-coronary artery lesions. [2023]