Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions

Study Overview
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Brief Summary
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The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.

Detailed Description
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The main objective of this study is to compare a Drug-coated Ballon with Drug-eluting stent in the treatment of coronary arty lesions in STEMI patients in de novo coronary lesions.The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.

Official Title
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Multicenter, Randomized, Open and Controlled Study of Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Device: Drug-coated balloon
* Device: Drug-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical criteria 1)over 18 years old 2)Angiographic confirmation of acute myocardial infarction 3)EKG prompts STEM basis 4)Sign informed consent Angiographic criteria 1)In situ coronary artery disease 2)The reference diameter of the target vessel was 2.5-3.5 mm and the length was less than 28 mm 3)Visual examination showed that the diameter of lesions in criminals was narrower than or equal to 80%. Exclusion Criteria: 1.Clinical criteria LVEF<30% Killip grading is greater than 3 Significant abnormalities in hemorrhagic quality or known coagulation function History of intracranial tumors, aneurysms, arteriovenous malformations or cerebral hemorrhage;There was a history of stroke or TIA in 6 months and gastrointestinal bleeding in 2 months.Major operations were performed within 6 weeks.Recent or known platelets < 100,000/mm3 or hemoglobin < 10 g/dL. Planned elective surgery may lead to early discontinuation of ADP receptor antagonists The expected survival time of patients with other systemic diseases, such as malignant tumors is less than 1 year 2.Angiographic criteria 1)Left main lesion 2)The grade of dissection is greater than or equal to grade C lesions. 3)Coronary artery bridge lesions 4)In-stent restenosis 5)Severe stenosis of non-criminal lesions requiring selective treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-coated ballon<br>Treatment of in suit coronary lesions with drug-coated balloon | Device: Drug-coated balloon<br>* Treatment of in suit coronary lesions with drug-coated balloon<br>|
| Active Comparator: Drug-eluting stent<br>Treatment of in suit coronary lesions with drug-eluting stent | Device: Drug-eluting stent<br>* Treatment of in suit coronary lesions with drug-eluting balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late luminal loss (LLL) | LLL was the difference between the in-segment minimal lumen diameter after the procedure and at angiographic follow-up, as evaluated by quantitative coronary angiography | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate (RR) | in-stent restenosis | 12-24 months | 
| Target lesion failure (TLF) | The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization | 12-24 months | 
| Target lesion thrombosis | Thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC). Regarding timing, ST was defined as early (<30 days), late (30 days to 1 year), or too late (>1 year) | 12-24 months | 
| MACE | Non-fatal acute myocardial infarction, severe arrhythmia, heart failure, cardiovascular death | 12-24 months |