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

Not Applicable

• Conditions: Acute Myocardial Infarction
• Interventions: Device: Drug-coated balloon; Device: Drug-eluting stent

• Registration Number: NCT04072081
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-26
• Last Update Submitted: 2019-08-26
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Study Start: 2019-09-30
• Primary Completion: 2020-09-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

1. Clinical criteria 1)over 18 years old 2)Angiographic confirmation of acute myocardial infarction 3)EKG prompts STEM basis 4)Sign informed consent
2. 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

1. LVEF<30%
2. Killip grading is greater than 3
3. Significant abnormalities in hemorrhagic quality or known coagulation function
4. 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.
5. Planned elective surgery may lead to early discontinuation of ADP receptor antagonists
6. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug-coated ballon	Drug-coated balloon	Treatment of in suit coronary lesions with drug-coated balloon
Drug-eluting stent	Drug-eluting stent	Treatment of in suit coronary lesions with drug-eluting stent

Primary Outcome Measures

Name	Time	Method
Late luminal loss (LLL)	9 months	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

Secondary Outcome Measures

Name	Time	Method
Target lesion failure (TLF)	12-24 months	The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization
Restenosis rate (RR)	12-24 months	in-stent restenosis
Target lesion thrombosis	12-24 months	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)
MACE	12-24 months	Non-fatal acute myocardial infarction, severe arrhythmia, heart failure, cardiovascular death