RESTORE Imaging: an OCT-IVUS Imaging Substudy of RESTORE Trial
- Conditions
- Acute Coronary Syndrome (ACS)
- Interventions
- Device: Drug-coated balloonDrug: Guideline-directed medical treatment
- Registration Number
- NCT06449274
- Lead Sponsor
- Harbin Medical University
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm
- 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°
- Subject must provide written informed consent before any study-related procedure
- 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 m^2 (as calculated by MDRD formula for estimated GFR)
- Left ventricular ejection fraction<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
- Life expectancy <2 years for any
- Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- The target lesion is located within 10 mm of the proximal or distal of stent
- The target lesion cannot be in the left main coronary artery
- The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is >2 mm with >50% of stenosis)
- The target lesion is located in severe calcification or tortuosity of vessels
- The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)
- The target lesion is located within the bypass graft artery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DCB treatment Guideline-directed medical treatment Non-flow limited vulnerable plaque will be treated by drug-coated balloon when the enrolled individual is randomized into DCB treatment group. The individual located in DCB treatment will receive guideline-directed medical treatment. Guideline-directed medical treatment Guideline-directed medical treatment Non-flow limited vulnerable plaque will be left with no intervention when the individual is randomized into guideline-directed medical treatment group. The individual will receive guideline-directed medical treatment alone. DCB treatment Drug-coated balloon Non-flow limited vulnerable plaque will be treated by drug-coated balloon when the enrolled individual is randomized into DCB treatment group. The individual located in DCB treatment will receive guideline-directed medical treatment.
- Primary Outcome Measures
Name Time Method Minimal lumen area (MLA) At 12 months OCT-MLA
- Secondary Outcome Measures
Name Time Method Absolute change and percent change of MLA; At 12 months 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.
Absolute change and percent change of maximum plaque burden (PB); At 12 months 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.
Absolute change and percent change of fibrous cap thickness (FCT); At 12 months 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.
Absolute change and percent change of maximum lipid arc; At 12 months 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.
Percentage of participants with FCT <75 μm At 12 months Percentage of participants with FCT <65 μm; At 12 months Percentage of participants with PB >65%; At 12 months Percentage of participants with PB >70%; At 12 months Percentage of participants with MLA <3.5 mm2; At 12 months Percentage of participants with maximal lipid arc >180°; At 12 months Percentage of participants with positive remodeling; At 12 months 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.
Percentage of participants with macrophages; At 12 months Macrophage will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Percentage of participants with lipid plaques; At 12 months Lipid plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Percentage of participants with microchannels; At 12 months Microchannels will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Percentage of participants with cholesterol crystal; At 12 months Cholesterol crystal will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Percentage of participants with calcification; At 12 months Calcification will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Percentage of participants with healed plaque; At 12 months Healed plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Percentage of participants with non-culprit plaque rupture. At 12 months Non-culprit plaque rupture will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging.
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China