The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome.
Subjects must be between 18 and 80 years of age
Subject must present with acute myocardial infarction or unstable angina planned for PCI
Successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or less than 0.8)
Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR >0.8
Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated
Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
Hypotension, shock, or need for mechanical support or intravenous vasopressors;
Creatinine clearance ≤30 ml/min/1.73 m² (as calculated by MDRD formula for estimated GFR)
Harbin Medical University
Lead sponsor
Shanghai Shenqi Medical Technology Co., Ltd
Collaborator