Acute Coronary Syndrome (ACS) Clinical Trial
Official title:
Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque: an OCT-IVUS Imaging Substudy (RESTORE Imaging)
Verified date | June 2024 |
Source | Harbin Medical University |
Contact | Haibo Jia |
Phone | 15945685291 |
jhb101180[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | June 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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, including paclitaxel, etc) that cannot be adequately pre-medicated 2. 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.) 3. Hypotension, shock, or need for mechanical support or intravenous vasopressors; 4. Creatinine clearance =30 ml/min/1.73 m^2 (as calculated by MDRD formula for estimated GFR) 5. Left ventricular ejection fraction<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others) 6. Life expectancy <2 years for any 7. Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint 8. 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. 9. The target lesion is located within 10 mm of the proximal or distal of stent 10. The target lesion cannot be in the left main coronary artery 11. The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is >2 mm with >50% of stenosis) 12. The target lesion is located in severe calcification or tortuosity of vessels 13. The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium) 14. The target lesion is located within the bypass graft artery |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang |
Lead Sponsor | Collaborator |
---|---|
Harbin Medical University | Shanghai Shenqi Medical Technology Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Minimal lumen area (MLA) | OCT-MLA | At 12 months | |
Secondary | 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. | At 12 months | |
Secondary | 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. | At 12 months | |
Secondary | 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. | At 12 months | |
Secondary | 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. | At 12 months | |
Secondary | Percentage of participants with FCT <75 µm | At 12 months | ||
Secondary | Percentage of participants with FCT <65 µm; | At 12 months | ||
Secondary | Percentage of participants with PB >65%; | At 12 months | ||
Secondary | Percentage of participants with PB >70%; | At 12 months | ||
Secondary | Percentage of participants with MLA <3.5 mm2; | At 12 months | ||
Secondary | Percentage of participants with maximal lipid arc >180°; | At 12 months | ||
Secondary | 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. | At 12 months | |
Secondary | Percentage of participants with macrophages; | Macrophage will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging. | At 12 months | |
Secondary | Percentage of participants with lipid plaques; | Lipid plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging. | At 12 months | |
Secondary | Percentage of participants with microchannels; | Microchannels will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging. | At 12 months | |
Secondary | Percentage of participants with cholesterol crystal; | Cholesterol crystal will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging. | At 12 months | |
Secondary | Percentage of participants with calcification; | Calcification will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging. | At 12 months | |
Secondary | Percentage of participants with healed plaque; | Healed plaque will be categorized into 0 representing its absence and 1 representing presence at 12 months imaging. | At 12 months | |
Secondary | 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. | At 12 months |
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