Eisenstadt

This research aims to gather real-world information on using intravascular lithotripsy (IVL) with the Shockwave IVL system to treat calcified lesions in the femoropopliteal and crural arteries of patients with chronic limb-threatening ischemia (CLTI). The main goal is to understand how effective IVL is in helping wounds heal and avoiding amputations. The study also looks at how well the treatment restores blood flow immediately, its safety, and its effect on patients' quality of life. Participants receive treatment with the Shockwave Medical IVL System, a comprehensive device that includes a generator, connector cable, and a single-use catheter with an integrated balloon designed to break up artery calcification. The study is observational and collects data on patients who undergo this treatment for their calcified arterial lesions. During the study, researchers will monitor wound healing and whether participants avoid amputation over 12 months. They will also assess how well the blood vessels open after treatment and track safety and quality of life outcomes. Participants will be followed to collect this information over the course of a year to understand the impacts of IVL treatment for CLTI.

This registry study collects information on the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System used in regular clinical practice across diverse real-world populations. It serves as a Post-Market Clinical Follow-up (PMCF) to monitor the device's use after it has been released to the market. The study is observational and prospective, involving multiple centers internationally to gather data on patient outcomes. The study will involve up to 10,000 patients treated with the BioFreedom Ultra stent, which combines a cobalt chromium stent platform with a polymer and carrier-free coating of the active ingredient BA9. Patients will be enrolled from as many as 150 interventional cardiology centers in up to 15 countries, including Europe, South America, the Middle East, and Asia, over a period of 5 years. Participants will be followed for 12 months after their percutaneous coronary intervention (PCI) procedure, primarily through telephone or clinic visits, to collect data. The main outcome measured is Target Lesion Failure (TLF) at 12 months. This follow-up helps assess the real-world performance and safety of the BioFreedom Ultra stent in everyday clinical use.