Pulse IVL for Peripheral Arterial Disease
(POWER PAD 2 Trial)
Recruiting in Palo Alto (17 mi)
+15 other locations
Overseen byChristopher Metzger, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Amplitude Vascular Systems, Inc.
Must not be taking: Antiplatelets, Anticoagulants, Thrombolytics
Disqualifiers: Infection, Amputation, Stroke, Renal disease, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345How 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.
12346Eligibility 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.
+7 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Pulse Intravascular Lithotripsy™ (Pulse IVL™)Experimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
OhioHealthColumbus, OH
Midwest Cardiovascular Research FoundationDavenport, IA
Vascular and Interventional Specialists of Orange CountyOrange, CA
Advanced Heart and Vein CenterThornton, CO
More Trial Locations
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Who Is Running the Clinical Trial?
Amplitude Vascular Systems, Inc.Lead Sponsor
References
The Epidemiology, Pathophysiology, and Novel Treatment of Calcific Arterial Disease. [2019]Endovascular treatment of arterial diseases has become first-line in most cases due to improved technology. However, until recently, excessive atherosclerotic calcification has been a major limiting factor in the endovascular management of peripheral arterial disease, as well as vascular access for endovascular aneurysm repair (EVAR) and transcatheter aortic valve replacement (TAVR). The Peripheral Intravascular Lithotripsy (IVL) System (Shockwave Medical, Inc., Fremont California) applies pulsatile mechanical energy under fluoroscopic guidance to disrupt calcified lesions. The purpose of this paper is to introduce IVL in the treatment of calcific access vessels in preparation for EVAR and TAVR, as well as peripheral arterial disease applications to enhance luminal gain. Using the IVL System, angioplasty can be performed with lower pressures, which may minimize arterial dissection. Further, the lithotripsy effect on calcium will enhance vessel compliance. We describe several cases where IVL was applied successfully and present additional cases that may have benefitted from the use of this technology.
Injury and Healing Response of Healthy Peripheral Arterial Tissue to Intravascular Lithotripsy: A Prospective Animal Study. [2022]Intravascular lithotripsy (IVL) is a novel clinical technique for the management of severely calcified lesions. However, the biological effects of shock wave on the healthy arterial tissue have not been demonstrated. The preclinical safety study aimed to investigate the vascular response to IVL shock wave compared to plain old balloon angioplasty (POBA) in porcine peripheral arteries.
Efficacy and Safety of Intravascular Lithotripsy in Lower Extremity Peripheral Artery Disease: A Systematic Review and Meta-Analysis. [2022]Intravascular lithotripsy (IVL) is a novel technique for plaque modification during endovascular revascularisation for peripheral artery disease (PAD) with severe calcification. The aim of this paper was to perform a systematic review and meta-analysis of contemporary data to elucidate the efficacy and safety of IVL in lower extremity PAD.
Acoustic Shock Waves to Modify Calcific Plaques - Intravascular Lithotripsy in the Peripheral Circulation. [2022]Intravascular lithotripsy (IVL) is a new technique for treatment of severely calcified lesions that uses acoustic shockwaves in a balloon-based system to induce fracture in calcific plaque, facilitating luminal gain and vessel expansion. In this review, we provide a concise summary of the available data and clinical experience of IVL in various peripheral vascular beds, including facilitating vascular access for large-bore devices. We discuss the physics and mode of action of IVL in modifying calcified plaques, include several illustrative examples of utility of IVL in peripheral interventions, and discuss the future directions for adoption of the technique in peripheral interventions.
Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: An individual patient-level pooled data analysis. [2021]Peripheral arterial disease (PAD) is one of the most common manifestations of atherosclerotic disease worldwide. Peripheral arterial calcification reduces acute success and long-term patency of endovascular therapy for PAD. Several calcium modification devices are available for use in peripheral interventions. Outcomes after peripheral intravascular lithotripsy (IVL), a novel approach using pulsatile sonic waves to treat luminal and medial calcium in patients with PAD, have not been extensively characterized. Therefore, we sought to perform an individual patient-level data (IPD) pooled analysis of available studies to evaluate the efficacy and safety of IVL in the treatment of PAD.
Use of intravascular lithotripsy in non-coronary artery lesions. [2023]Intravascular lithotripsy (IVL) is a novel technique increasingly used for plaque modification and endovascular revascularization in patients with severe calcification and peripheral artery disease. However, much of the available literature on IVL is focused on its use in coronary arteries, with relatively limited data on non-coronary artery use.