A Prospective, Open-Label, Multi-Country, Multicentre, Observational Post Market Surveillance of VIVO ISAR (Polymer-Free Sirolimus Eluting Coronary Stent System) in Real World Patients Undergoing PCI with Short Dual Antiplatelet Therapy

What this Trial Is About

Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease (CAD). This observational registry focuses on individuals treated with this specific stent and planned for a short dual antiplatelet therapy (DAPT) of up to 3 months. The study aims to collect real-world data on clinical outcomes including safety and effectiveness over a 12-month period. Participants in this single-arm registry have undergone percutaneous coronary intervention (PCI) using the Vivo ISAR stent and will receive standard care short DAPT treatment for no more than 3 months. The study does not affect treatment choices or standard care procedures. After the PCI, eligible patients will be invited to join the registry and followed up at 1 month, 3 months, and 12 months. During the study, researchers will collect baseline medical data and conduct telephonic follow-ups at 30 days, 3 months, and 12 months. These follow-ups will check on medication use, laboratory assessments, adverse events, and any further interventions. The main outcomes measured include ischemic and bleeding events at 12 months, along with secondary outcomes such as mortality, heart attacks, strokes, stent thrombosis, and need for additional vessel treatments. The total participation duration is one year from the PCI procedure.

A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)