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Acute ST segment elevation myocardial infarction (STEMI) has a high disability mortality rate, and timely reperfusion treatment can significantly reduce the mortality of patients. Emergency PCI is the preferred strategy for STEMI treatment recommended by domestic and international guidelines. The long-term existence of stents can never completely avoid the formation of thrombosis in the stents and affect the relaxation and contraction of criminal blood vessels. Drug coated balloon provides a new concept and technology of interventional therapy for coronary artery disease in the form of "intervention without implantation". Through balloon dilation of local blood vessels to release anti proliferative drugs to coronary artery wall and inhibit intimal hyperplasia, it can not only treat serious coronary artery disease, improve coronary blood supply and vascular function, but also not leave permanent implants in the blood vessels; The main pathogenesis of STEMI is thrombosis based on the rupture or erosion of coronary atheromatous plaque. In terms of pathophysiological mechanism, drug coated balloons are also suitable for STEMI patients without obvious thrombosis or severe dissection after full pretreatment. The two-dimensional lumen images obtained by traditional coronary angiography can not directly reflect the vessel wall, so we can not evaluate the actual size of the vessel, plaque characteristics and the effect of intervention through coronary angiography; Optical coherence tomography (OCT) uses near-infrared scanning to produce high-resolution tissue microscopic images with a resolution of up to 10 μ m. It can clearly observe the three-layer structure of coronary artery, find abnormal intima structure, and more clearly identify thrombosis, dissection, plaque erosion or collapse in coronary artery, providing more valuable information for optimizing interventional treatment. Therefore, the application of drug coated balloon under the guidance of OCT in STEMI can provide a more accurate and optimized diagnosis and treatment scheme for STEMI patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Drug-coated Balloon (Lepu Medical Technology (Beijing) Co.,Ltd.) |
|
| Control group | Active Comparator | Drug Eluting Stent(Microport Medical) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-eluting balloon | Device | Drug eluting balloon was used in the experimental group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss rate | 10 months after discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Revascularization rate of target lesions | 10 months after discharge. | |
| Target vessel revascularization rate | 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junhui Zhang, Dr | Contact | +86 0371 58681033 | 09junhuizhang@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Central China Cardiovascular Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Drug-eluting stent | Device | Drug eluting stent was used in the control group |
|
| Major Adverse Cardiovascular Events | 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge. |
| Cardiovascular death | 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge. |
| Recurrent acute myocardial infarction | Time-to-onset for recurrent acute myocardial infarction, as ascertained according to follow-up | 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge. |
| Stroke | Time-to-onset for stroke, as ascertained according to follow-up | 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge. |
| All cause of death | 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge. |
| Unstable angina | Time-to-onset for unstable angina, as ascertained according to follow-up | 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |