Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery 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 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.
⁃ Candidates will be included in the study only if all of the following conditions are met:
• 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.
⁃ Angiographic Inclusion Criteria
⁃ Candidates will be included in the study only if all of the following intraoperative conditions are met:
• Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
• 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).
• Target lesion reference vessel diameter is between 4.0 mm and 6.5 mm by visual estimate.
• Target zone is ≤ 150 mm in total contiguous treatable length. Target lesion can be all or part of the 150 mm zone.
• Target lesion is ≥70% stenosis via visual estimate.
• 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%.
• Ability to pass the guidewire across the atherosclerotic lesion, without the use of re-entry devices.
• No evidence of aneurysm or acute or chronic thrombus in target vessel.
• 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.)