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.
The present study is an integrated imaging substudy of randomized, controlled and intervention trial of preventive drug-coated balloon angioplasty in vulnerable atherosclerotic plaque (RESTORE). The RESTORE Imaging trial will equally enroll from the DCB arm and GDMT arm to at least 180 consecutive individuals to validate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in enlarge luminal dimensions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed. Individual will receive guideline-directed medical treatment.
All individuals will receive guideline-directed medical treatment.
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGMinimal lumen area (MLA)
OCT-MLA
Time frame: At 12 months
Absolute change and percent change of MLA;
Absolute change of MLA (mm2) is defined as the difference between baseline and follow-up MLA in OCT imaging. Percent change of MLA (%) is defined as absolute change of MLA divided by baseline MLA.
Time frame: At 12 months
Absolute change and percent change of maximum plaque burden (PB);
Absolute change of maximum PB (%) is defined as the difference between baseline and follow-up PB in IVUS imaging. Percent change of plaque burden (%) is defined as absolute change of PB divided by baseline PB.
Time frame: At 12 months
Absolute change and percent change of fibrous cap thickness (FCT);
Absolute change of FCT (μm) is defined as the difference between baseline and follow-up FCT in OCT imaging. Percent change of FCT (%) is defined as absolute change of FCT divided by baseline FCT.
Time frame: At 12 months
Absolute change and percent change of maximum lipid arc;
Absolute change of maximum lipid arc (°) is defined as the difference between baseline and follow-up maximum lipid arc in OCT imaging. Percent change of maximum lipid arc (%) is defined as absolute change of maximum lipid arc divided by baseline maximum lipid arc.
Time frame: At 12 months
Percentage of participants with FCT <75 μm
Time frame: At 12 months
Percentage of participants with FCT <65 μm;
Time frame: At 12 months
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Percentage of participants with PB >65%;
Time frame: At 12 months
Percentage of participants with PB >70%;
Time frame: At 12 months
Percentage of participants with MLA <3.5 mm2;
Time frame: At 12 months
Percentage of participants with maximal lipid arc >180°;
Time frame: At 12 months
Percentage of participants with positive remodeling;
Positive remodeling is defined as Remodeling index (cross sectional area (CSA) of external elastic membrane (EEM) in lesion divided by CSA of EEM in reference vessel) \>1.05.
Time frame: At 12 months
Percentage of participants with macrophages;
Macrophage will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Time frame: At 12 months
Percentage of participants with lipid plaques;
Lipid plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Time frame: At 12 months
Percentage of participants with microchannels;
Microchannels will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Time frame: At 12 months
Percentage of participants with cholesterol crystal;
Cholesterol crystal will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Time frame: At 12 months
Percentage of participants with calcification;
Calcification will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Time frame: At 12 months
Percentage of participants with healed plaque;
Healed plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Time frame: At 12 months
Percentage of participants with non-culprit plaque rupture.
Non-culprit plaque rupture will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Time frame: At 12 months