Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial

Egyéb feltételek

• General Inclusion Criteria
• 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.); General Exclusion Criteria; Candidates will be excluded from the study if any of the following conditions are present:
• 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
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated
• Known allergy to any Pulse IVL product materials
• Clinically significant myocardial infarction within 60 days prior to enrollment
• History of stroke within 60 days prior to enrollment
• History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment
• History of thrombolytic therapy within two weeks of enrollment
• 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
• Pregnant or nursing
• Participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
• 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:
• The use of chronic total occlusion (CTO) re-entry devices
• Chronic Total Occlusion (CTO) greater than 40mm in length
• Any in-stent restenosis within the target zone
• Lesions within 10 mm of ostium of the SFA
• Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon)
• Target lesion within surgical bypass grafts
• 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
• Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target lesion at the time of the enrollment/index procedure