The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).
The main question[s] it aims to answer are:
Is the Thor system safe in treating these lesions
Does the Thor system work to treat these lesions
Participants will:
Receive treatment with the Thor system
Have follow-up visits at Discharge, 30 days, 6 months, and 12 months
Clinical Feasibility of the Myotrace Measurement
To evaluate the feasibility of the MYOTRACE NRD (Neural Respiratory Drive) index as an aid to assess the respiratory status of a patient (improving or stable versus deteriorating) as compared to a specialist in thoracic medicine's evaluation in a general care setting.
A Post Market Clinical Follow-up Study to Evaluate the Safety and Clinical Performance of the Tempus Pro, a Multi-parameter Vital Signs Monitoring Device With Specific Reference to ECG Recordings and Data Transmission Using Telemedicine
A multicenter, prospective and retrospective, observational, post market study.
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