Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial (NCT06457685) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial
United States115 participantsStarted 2024-09-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able and willing to comply with all assessments in the study.
. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
. \>18 years old
. Rutherford Clinical Category 2, 3, or 4 of the target limb
. Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg OR ≥70% stenosis by prior imaging (CT/MR angiogram, DUS).
. Subjects has de novo lesions who are felt to have indication for peripheral angiography and endovascular intervention by the investigator per their standard of care.
. Estimated life expectancy \>1 year, in the opinion of the investigator at the time of screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
Exclusion criteria
. Rutherford Clinical Category 0, 1, 5 and 6.
. Active infection in the target leg.
. Planned major amputation of the target leg (transmetatarsal or higher).
. History of prior endovascular or surgical procedure on the target limb within the past 30 days.
. Retrograde pedal/tibial access for intervention.
. Known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet count \< 100,000/microliter, or International Normalized Ratio (INR) \>1.5.
. Lesion in contralateral limb requiring intervention within the next 30 days.
. Subject contraindicated for antiplatelet, anticoagulant, or thrombolytic therapy.