A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)

Peripheral artery disease (PAD) happens when plaque and calcium build up inside the arteries of the legs. This buildup narrows the arteries and limits blood flow, which can cause pain, limited mobility, and slow healing of wounds. Treating arteries that contain a large amount of calcium can be difficult because the calcium makes the artery wall stiff and hard to open with standard balloons or stents.

The FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is designed to improve treatment for people with moderate to severe calcium in their leg arteries. The system includes a generator and a small balloon catheter that emits short bursts of sound energy (lithotripsy). These sound waves gently fracture calcium deposits while protecting the softer tissue of the artery. After the calcium is cracked, the artery can be widened using low balloon pressure, which may help blood flow more easily and lower the risk of tearing or other damage.

This prospective, multi-center, single-arm clinical study will evaluate the safety and effectiveness of the FastWave Artero™ IVL System in adults with PAD who have calcified blockages in the femoral or popliteal arteries. The study will enroll up to 110 participants at as many as 30 U.S. investigational sites. All participants will receive the FastWave IVL treatment during a standard minimally invasive endovascular procedure.

The primary safety endpoint is the proportion of participants free from major adverse events (such as serious vessel injury, emergency surgery, or unplanned major amputation) through 30 days after the procedure.

The primary effectiveness endpoint is successful treatment of the blocked artery, defined as less than 50 percent narrowing remaining after IVL, with or without the use of additional devices.

Secondary assessments will include degree of residual narrowing (≤30%), use of adjunctive therapies, and improvements in vessel patency and clinical symptoms through 6 months. These data will also be used to compare outcomes to a historical performance goal based on prior intravascular lithotripsy studies in peripheral arteries.

Participants will be followed at discharge, 30 days, and 6 months to assess safety, vessel imaging, and symptom changes. A small number of sites will also participate in an optional intravascular ultrasound (IVUS) sub-study to collect detailed imaging data on how the FastWave device interacts with the artery wall.

Findings from this pivotal study are intended to support a future U.S. Food and Drug Administration (FDA) 510(k) submission for the FastWave Artero™ Peripheral IVL System as a treatment for calcified peripheral arterial disease.

Inclusion criteria

• Subject is able and willing to comply with all assessments in the study.
• Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
• Subject is ≥ 18 years of age.
• Rutherford Clinical Category 2, 3 or 4
• Resting ABI of ≤0.90, or ≤0.75 after exercise, of the target leg.
• Lesion calcification is moderate or severe using the PARC3calcium classification definition, or by intravascular ultrasound (IVUS) determined by the investigator.

• Moderate is defined as ≥ 180º to 270º and < 50% of the total lesion length.
• Severe is defined as >270º and > than 50% of the total lesion length.
• Estimated life expectancy >1 year, in the opinion of the investigator at the time of enrollment.
• Target lesion that is in a native de novo femoral-popliteal arteries. Non-target lesions can be in the iliac arteries (inflow).
• The subject is a suitable candidate for angiography and endovascular intervention, in the investigator's opinion or per the hospital guidelines.
• In the opinion of the investigator by visual estimate, the target lesion is ≥70% stenosis or is occluded.
• According to the visual estimate, the target lesion reference vessel diameter is between 3.5mm and 8.0mm.
• The total planned target lesion length must be ≤220 mm.

• Tandem lesions (i.e., two or more lesions in close proximity) may be considered a single lesion if the distance between them is ≤ 30 mm.
• Multiple target vessel beds and discrete (non-contiguous) lesions may be treated, provided the combined total length of all treated lesions does not exceed 220 mm.
• Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis >50% distal to the target lesion.

a. If the peroneal artery, at least one collateral must supply the foot.

• Retrograde access is permitted for lesion crossing; however, the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System must be deployed from antegrade (either ipsilateral or contralateral) access.

Exclusion criteria

• Planned use of atherectomy, scoring or cutting balloons, or any investigational device other than lithotripsy.
• Rutherford Clinical Categories 0, 1, 5, and 6.
• The investigator determined no or mild calcium in the target lesion.
• Subject has outflow disease in which no tibial vessel has <50% stenosis. Staged or concomitant intervention to the tibial vessels is not allowed.
• The subject has significant inflow disease, defined as >50% stenosis or occlusion in the inflow tract proximal to the target lesion, that has not been successfully treated prior to treatment of the superficial femoral artery (SFA) or popliteal lesion.

a. Successful treatment is defined as residual stenosis ≤30% without a flow-limiting dissection or vessel perforation.

• The subject has significant outflow disease in which no tibial vessel has <50% stenosis. Staged or concomitant intervention to the tibial vessel is not allowed.
• Inability to pass the guidewire across the target lesion.
• In-stent restenosis within the lesion(s) to be treated.
• Lesions within autologous or synthetic vessel grafts.
• Evidence of aneurysm or thrombus in the vessels to be treated.
• History of prior endovascular or surgical intervention on the index limb within 14 days prior to the index procedure, unless part of a pre-specified, staged treatment plan.
• Intervention on the contralateral limb is required within the next 14 days.
• History of thrombolytic therapy within two weeks of enrollment.
• Subject has a known hypercoagulable state, coagulopathy, or has a bleeding diathesis, thrombocytopenia with platelet counts less than 100,000/microliter, or International Normalized Ratio (INR) >1.5.
• Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
• 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.
• Subject has acute or chronic renal disease defined as serum creatinine of >2.5 mg/dL or >220 µmol/L, or on dialysis.
• Subject has an active infection requiring antibiotic therapy.
• Subject has known allergy to contrast agents, medications, or catheter materials used to perform endovascular intervention that cannot be adequately pre-treated.
• Subject is pregnant or nursing.
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
• Subject has 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.