Clinical trial NCT04072081: Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Late luminal loss (LLL)
timeFrame: 9 months
Secondary outcomes:
measure: Restenosis rate (RR)
timeFrame: 12-24 months
measure: Target lesion failure (TLF)
timeFrame: 12-24 months
measure: Target lesion thrombosis
timeFrame: 12-24 months
measure: MACE
timeFrame: 12-24 months
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital Zhejiang University School of Medicine
name: Jiang Jun, PhD
role: STUDY_DIRECTOR
References: