Study of Scaffold Implantation for Coronary Artery Disease in Emilia-Romagna and MAGIC Networks Observing Long-Term Safety and Performance in Real-World Settings

What this Trial Is About

Researchers are evaluating the clinical performance and long-term safety of scaffold implantation for patients with coronary artery disease in a real-world regional setting. This observational prospective study involves two networks of centers, including all cath-labs in Emilia-Romagna and centers from the MAGIC retrospective study. Investigators have agreed on specific indications and implantation strategies to ensure consistency across centers. The treatment being studied is the implantation of at least one scaffold device during percutaneous coronary intervention PCI. The study focuses on complete revascularization in patients under 65 years, long lesion revascularization especially in the left anterior descending artery, and spontaneous coronary dissection. Implantation strategies include mandatory predilation, precise sizing, avoiding vessels outside specific diameter ranges, and mandatory postdilation with a non-compliant balloon. Participants will be enrolled after approval and followed for safety and outcomes, with adverse events monitored continuously by a Data Safety Monitoring Board. All coronary angiographies and interventions are reviewed by an independent core laboratory to assess adherence to implantation techniques. The primary outcome measured is device-oriented cardiac events at one year, with study participation lasting at least one year to ensure follow-up and compliance.

Scaffold in Emilia Romagna and in the MAGIC Network