Eisenstadt

Researchers are collecting real-world data on the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System in patients who have undergone percutaneous coronary intervention PCI. This prospective, observational registry study involves up to 10,000 patients treated at up to 150 cardiology centers across Europe, South America, the Middle East, and Asia over five years. The study provides post-market clinical follow-up as part of ongoing post-market surveillance. Participants receive the BioFreedom Ultra device, which consists of a cobalt chromium stent platform coated on the outside with the active ingredient BA9, without polymer or carrier. The study observes the use of this device in standard clinical practice without altering patient care. Patients are monitored mainly through telephone or clinic visits one year after PCI. During the study, participants will be followed for 12 months to collect data on outcomes such as target lesion failure, clinically driven target lesion revascularization, cardiovascular death, target vessel myocardial infarction, target vessel revascularization, and stent thrombosis. Follow-up assessments are conducted primarily by phone, ensuring safety monitoring and data collection in a real-world setting with minimal disruption to participants routine care.

Researchers are evaluating the safety and efficacy of intravenous thrombolysis IVT in adults who have experienced an acute ischemic stroke AIS and have taken direct oral anticoagulants DOAC within the last 48 hours. This international, multicenter, randomized trial compares IVT plus standard care to standard care alone in 906 participants to determine if IVT leads to better outcomes 90 days after treatment. Participants are randomly assigned to one of two groups one receives intravenous Tenecteplase or Alteplase along with the best medical treatment following local guidelines, while the other receives only the best medical treatment. The treatment is administered according to current recommendations from leading stroke organizations. The study aims to test whether IVT is superior in improving recovery in AIS patients with recent DOAC intake. During the study, participants are monitored and evaluated at multiple time points, including assessments of stroke severity, functional outcomes using the Modified Rankin Scale at 90 days, and quality of life questionnaires. Safety and efficacy are carefully tracked through these measures. Participants progress is followed up to about 90 days after randomization to assess the main outcomes and overall health status.