RESTORE Imaging: an OCT-IVUS Imaging Substudy of RESTORE Trial
Trial Parameters
Brief Summary
The objective of this imaging substudy of RESTORE 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 plaque stabilization in patients with acute coronary syndrome.
Eligibility Criteria
Inclusion Criteria: 1. Subjects must be between 18 and 80 years of age 2. Subject must present with acute myocardial infarction or unstable angina planned for PCI 3. 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) 4. Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR \>0.8 5. Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm 6. Target lesion must have any two of the intravascular imaging criteria of PB \>65%, MLA \<3.5 mm\^2 (OCT) or 4.0mm\^2 (IVUS), FCT \<75 μm, or maximal lipid arc \>180° 7. Subject must provide written informed consent before any study-related procedure Exclusion Criteria: 1. 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, inclu