IQVIA Holdings ((IQV)) announced an update on their ongoing clinical study.
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Study Overview: The study titled ‘A Prospective, Open-Label, Multi-Country, Multicentre, Observational PoSt Market SurvEillance of VIVO ISAR’ aims to assess the safety and performance of the Polymer-Free Sirolimus Eluting Coronary Stent System in patients with coronary artery disease. The key objective is to evaluate clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) with a short dual antiplatelet therapy (DAPT) regimen, highlighting its significance in real-world applications.
Intervention/Treatment: The intervention being tested is the Vivo ISAR, a polymer-free sirolimus-eluting coronary stent system. Its intended purpose is to treat coronary artery disease effectively while minimizing the duration of DAPT, potentially reducing associated risks.
Study Design: This is an observational study with a prospective time perspective. It involves multiple centers across various countries, focusing on real-world patients. The study does not involve random allocation or masking, as it aims to observe outcomes in a naturalistic setting.
Study Timeline: The study commenced on May 8, 2024, with the latest update submitted on September 14, 2025. These dates are crucial as they mark the progress and current status of the study, which is still recruiting participants.
Market Implications: The update on this study could influence investor sentiment positively towards IQVIA Holdings and Translumina Therapeutics, as successful outcomes may enhance their market position in the cardiovascular treatment sector. Competitors in the stent market may need to adjust strategies if the Vivo ISAR demonstrates superior safety and performance.
The study is ongoing, with further details available on the ClinicalTrials portal.