Condition: Coronary Arterial Disease (CAD) · NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI) · Stable Angina, Unstable Angina, NSTEMI · Sponsor: Fundación Interhospitalaria para la Investigación Cardiovascular FIC
This prospective, multicenter, post-market observational study aims to evaluate the safety and effectiveness of the crystalline sirolimus-coated balloon (SeQuent® Sirolimus-Coated Balloon) for the treatment of coronary artery disease in routine clinical practice. Consecutive, unselected adult patients undergoing percutaneous coronary intervention for de novo coronary lesions or in-stent restenosis will be enrolled. The primary objective is to assess target lesion failure at 12 months, defined as the composite of target vessel myocardial infarction or ischemia-driven target lesion revascularization. Secondary objectives include angiographic procedural success, major adverse cardiovascular events, bleeding outcomes, and longer-term clinical results up to 36 months, as well as outcomes across predefined anatomical and clinical subgroups. The study seeks to answer whether treatment with the crystalline sirolimus-coated balloon provides a safe and effective revascularization strategy in a real-world population with diverse clinical presentations and lesion characteristics.
This description comes directly from the study's public registry record.
Víctor A Jiménez Díaz, MD, MPH · +34986825564 · victor.alfonso.jimenez.diaz@sergas.es
Pablo Juan-Salvadores, Pharma, MPH, PhD · +34986825564 · pablo.juan@iisgaliciasur.es
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| Hospital Álvaro Cunqueiro | Vigo, Pontevedra, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07444957