Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 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.

POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular System (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. This study will enroll subjects \>18 years old that are presenting for a peripheral arterial disease intervention for the treatment of peripheral artery disease. Specifically, the subject has moderate to heavily calcified superficial femoral and popliteal arteries, presenting with Rutherford Category 2 to 4 of the target limb, with a reference vessel diameter (RVD) of 4mm to 6.5mm and a total lesion length of ≤ 150mm. Up to 120 subjects will be treated in the study at up to 20 U.S. investigational sites. Subjects will be evaluated at discharge, 30 days and 6 months after procedure.

Eligibility Criteria:
General Inclusion Criteria

Candidates will be included in the study only if all of the following conditions are met:

1. Able and willing to comply with all assessments in the study.
2. 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.
3. \>18 years old
4. Rutherford Clinical Category 2, 3, or 4 of the target limb
5. 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).
6. 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.
7. Estimated life expectancy \>1 year, in the opinion of the investigator at the time of screening.

Angiographic Inclusion Criteria

Candidates will be included in the study only if all of the following intraoperative conditions are met:

1. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
2. Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to 2 cm above the bifurcation, or trifurcation, of the tibial artery).
3. Target lesion reference vessel diameter is between 4.0 mm and 6.5 mm by visual estimate.
4. Target zone is ≤ 150 mm in total contiguous treatable length. Target lesion can be all or part of the 150 mm zone.
5. Target lesion is ≥70% stenosis via visual estimate.
6. Subject has at least one patent tibial vessel on the target leg with runoff to the ankle (not supported by collateral circulation.) Tibial vessel patency is defined as no stenosis \>50%.
7. Ability to pass the guidewire across the atherosclerotic lesion, without the use of re-entry devices.
8. No evidence of aneurysm or acute or chronic thrombus in target vessel.
9. Calcification is at least moderate. (Presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion.)

General Exclusion Criteria

Candidates will be excluded from the study if any of the following conditions are present:

1. Rutherford Clinical Category 0, 1, 5 and 6.
2. Active infection in the target leg.
3. Planned major amputation of the target leg (transmetatarsal or higher).
4. History of prior endovascular or surgical procedure on the target limb within the past 30 days.
5. Retrograde pedal/tibial access for intervention.
6. Known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet count \< 100,000/microliter, or International Normalized Ratio (INR) \>1.5.
7. Lesion in contralateral limb requiring intervention within the next 30 days.
8. Subject contraindicated for antiplatelet, anticoagulant, or thrombolytic therapy.
9. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
10. Known allergy to any Pulse IVL product materials.
11. Clinically significant myocardial infarction within 60 days prior to enrollment.
12. History of stroke within 60 days prior to enrollment.
13. History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
14. History of thrombolytic therapy within two weeks of enrollment.
15. Acute or chronic renal disease (e.g., as measured by a serum creatinine of \>2.5 mg/dL or \>220 umol/L), or on dialysis.
16. Pregnant or nursing.
17. Participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
18. Other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.

Angiographic Exclusion Criteria

Candidates will be excluded from the study if any of the following intraoperative conditions are met:

1. The use of chronic total occlusion (CTO) re-entry devices.
2. Chronic Total Occlusion (CTO) greater than 40mm in length.
3. Any in-stent restenosis within the target zone.
4. Lesions within 10 mm of ostium of the SFA.
5. Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
6. Target lesion within surgical bypass grafts.
7. Subject has significant stenosis (\>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated without complications.
8. Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target lesion at the time of the enrollment/index procedure.