The purpose of this clinical study is to learn if the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is safe and works well to help people with peripheral artery disease (PAD) who have hard, calcium-filled blockages in their leg arteries.
The study will test the idea that using sound waves inside the artery can safely break up calcium and make it easier to open the artery so blood can flow better.
The main question this study is trying to answer is:
Can treatment with the FastWave Artero™ IVL System safely widen blocked leg arteries and lower the chance of serious problems during or after the procedure?
About 110 adults at up to 30 medical centers in the United States will take part. Everyone in the study will receive the IVL treatment.
During the study, participants will:
Have a minimally invasive procedure using the FastWave IVL System
Stay for a short observation period after the procedure
Return for follow-up visits about 30 days and 6 months later
Researchers will look at how well the arteries open, how long they stay open, and whether any major complications occur. The results will help determine if the FastWave Artero™ IVL System can be used as a safe and effective treatment for people with PAD and severe calcium buildup in the leg arteries.
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
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.
Single group
FastWave Artero™ Peripheral IVL System
DeviceThe FastWave Artero™ Peripheral IVL System includes a generator and a balloon-based catheter designed to treat calcified blockages in peripheral arteries. During a single endovascular index procedure, the catheter is positioned within the target femoropopliteal artery and inflated at low pressure. The device emits short bursts of pulsatile sonic pressure waves that fracture calcium deposits, improving vessel flexibility and allowing dilation at low balloon pressures to restore blood flow. Multiple inflations may be performed as needed. Adjunctive angioplasty or stenting may be used at the investigator's discretion.
Procedural Success
Procedural success is defined as ≤50% residual stenosis in the target lesion after treatment with the FastWave Artero™ IVL System, with or without adjunctive therapy (e.g., angioplasty or stenting).
Freedom from Major Adverse Events (MAE) at 30 Days
The percentage of subjects free from major adverse events (MAE) through 30 days following the index procedure. MAE is defined as unplanned surgical revascularization of the target limb, major amputation of the target limb, symptomatic thrombosis or embolism requiring intervention, vessel perforation requiring covered stent, or unresolved flow-limiting dissection.
Residual Stenosis ≤30%
The percentage of subjects achieving ≤30% residual stenosis in the target lesion as measured by angiography following treatment.
Incidence of Adjunctive Therapy
The percentage of subjects requiring adjunctive therapy (angioplasty, stent placement, or other devices) to achieve procedural success.
Primary Patency
The percentage of target lesions maintaining primary patency, defined as freedom from clinically driven target lesion revascularization and duplex ultrasound evidence of ≤50% restenosis.
Freedom from Major Adverse Events (MAE) at 6 Months
The percentage of subjects free from MAE through 6 months following the index procedure, using the same MAE definition as the primary safety endpoint.
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FastWave Medical
Lead sponsor
Rede Optimus Hospitalar SA
Collaborator
Medical Metrics Diagnostics, Inc
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
