Pulse IVL for Peripheral Arterial Disease

(POWER PAD 2 Trial)

Recruiting at 21 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Pulse Intravascular Lithotripsy (Pulse IVL) for individuals with peripheral arterial disease (PAD). The goal is to determine if Pulse IVL can safely and effectively open blocked leg arteries narrowed by calcium build-up. Candidates suitable for this trial have significant leg artery narrowing and experience symptoms like leg pain while walking. The trial aims to provide a new option for those dealing with leg artery blockages. As an unphased trial, it offers patients access to innovative treatments that might not be available elsewhere.

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 prior data suggests that the Pulse Intravascular Lithotripsy is safe for treating peripheral arterial disease?

Research has shown that the Pulse Intravascular Lithotripsy (Pulse IVL) system is generally safe for treating peripheral artery disease. In one study, 94 out of 95 patients did not experience major problems within 30 days after treatment. Only one patient required an unexpected major amputation in the treated limb. These findings suggest that most patients tolerate the treatment well. While these results are encouraging, individual experiences can differ, so discussing potential risks with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Pulse Intravascular Lithotripsy (Pulse IVL) is unique because it uses sound waves to break up calcified plaques in blood vessels, which is a different mechanism compared to traditional treatments like angioplasty or atherectomy. Most standard treatments physically push or cut through blockages, but Pulse IVL targets and fragments the calcium, making it easier to open up the vessel. Researchers are excited about this approach because it could potentially lead to fewer vessel injuries and better long-term outcomes for patients with Peripheral Arterial Disease.

What evidence suggests that Pulse IVL is effective for peripheral arterial disease?

Research has shown that the Pulse Intravascular Lithotripsy (Pulse IVL) System, which participants in this trial will receive, effectively treats peripheral arterial disease. In a study with 95 patients, the treatment proved safe and effective within just 30 days. Pulse IVL uses sound waves to break up calcium build-up in arteries, aiding blood flow. Tests on patients with severely narrowed arteries demonstrated significant improvements in artery expansion. This suggests that Pulse IVL could be a promising option for those with calcified arteries needing better blood flow. ^{1 2 4 6 7}

Who Is on the Research Team?

Christopher Metzger, MD

Principal Investigator

Ohio Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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) 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) 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]

Citations

1.

evtoday.com

evtoday.com/news/power-pad-ii-study-data-presented-for-avs-pulse-ivl-system

POWER PAD II Data Presented for AVS Pulse IVL System

“The POWER PAD II study has provided outstanding safety and efficacy data in 95 patients at 30 days,” commented Dr. Metzger in the AVS press ...

2.

hmpgloballearningnetwork.com

hmpgloballearningnetwork.com/site/cathlab/news/power-pad-ii-study-avs-announces-positive-safety-and-effectiveness-data-first-95

POWER PAD II Study: AVS Announces Positive Safety and ...

The POWER PAD II study has provided outstanding safety and efficacy data in 95 patients at 30 days," said Dr. Chris Metzger.

3.

avspulse.com

avspulse.com/peripheral-clinical-evidence/

Peripheral Clinical Evidence

When tested in multiple cadaveric models with peripheral artery disease, Pulse IVL™ was able to achieve luminal expansion and produce full-thickness calcium ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06457685

Amplitude Vascular Systems (AVS) Lithotripsy POWER ...

The Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7187419/

An individual patient‐level pooled data analysis

The present patient‐level pooled analysis demonstrates that IVL treatment of significantly calcified lesions in patients with PAD is both effective and safe ...

6.

biospace.com

biospace.com/press-releases/avs-announces-positive-safety-and-effectiveness-data-in-first-95-patients-treated-in-pulse-ivl-ide-study

AVS Announces Positive Safety and Effectiveness Data in ...

Through 30 days, there was one reported MAE (unplanned target limb major amputation) and 94 of 95 subjects had a final residual stenosis <50%.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1553838923000052

Pulsatile Intravascular Lithotripsy: A Novel Mechanism for ...

A series of clinical trials called the DISRUPT studies have shown that SW-IVL is safe and effective in treatment of peripheral artery disease. Although ...