Agrigento

Researchers are evaluating the clinical performance and long-term safety of bioabsorbable scaffold implantation for treating coronary artery disease in a real-world regional setting. This observational prospective study involves two networks of centers in the Emilia-Romagna region and the MAGIC retrospective study participants, working together under a unified protocol. The study aims to address limitations of current permanent metallic stents, such as thrombosis and restenosis, by investigating newer scaffold devices. Participants will receive scaffold implantation, including devices like Magmaris or Desolve, following specific strategies agreed upon by investigators. These include mandatory predilatation, 1:1 sizing, avoiding vessels with diameters outside 2.8 to 3.8 mm or severe calcifications, and mandatory postdilation with a non-compliant balloon at least 0.5 mm larger than the scaffold diameter. The study focuses on patients under 65 years, complete revascularization, long lesions especially in the left anterior descending artery, and spontaneous coronary dissection. During the study, all adverse events will be monitored continuously by a Data Safety Monitoring Board. Coronary angiographies and interventions will be independently reviewed by a core laboratory to assess implantation techniques and outcomes. The primary outcome is the occurrence of device-oriented cardiac events over one year. Participants must provide informed consent and agree to at least one year of follow-up and compliance with dual antiplatelet therapy. The study duration includes enrollment and a one-year follow-up period.

Researchers are evaluating the effectiveness of ravulizumab compared to a placebo in reducing proteinuria and improving kidney function in adults with Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression. This Phase 3 study involves participants who have a confirmed diagnosis of IgAN and are receiving stable standard treatments for their condition. The study aims to provide important information about the impact of ravulizumab on kidney health over time. About 510 eligible participants will join the study. Around 450 will be randomly assigned to receive either ravulizumab or a placebo through weight-based intravenous infusions. Participants will continue their stable IgAN treatments during the study. An additional group of approximately 60 participants with more advanced kidney disease will also be enrolled. After Week 106, all participants have the option to enter an open-label phase to receive ravulizumab. Participants will be monitored through urine tests measuring protein levels and kidney function assessments over the course of the study. Key outcomes include changes in proteinuria at Week 34 and kidney filtration rate at Week 106. Safety and treatment effects will be closely observed throughout the study and during any extended access periods. The study includes thorough screening and follow-up assessments to track progress and ensure participant well-being.