Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Shenqi Medical Technology Co., Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB treatment | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-coated balloon | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal lumen area (MLA) | OCT-MLA | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Absolute change and percent change of maximum plaque burden (PB); |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haibo Jia | Contact | 15945685291 | jhb101180@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bo Yu | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Guideline-directed medical treatment | Drug | All individuals will receive guideline-directed medical treatment. |
|
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 |
| 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 |
| 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 |
| 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; | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |