Acute Myocardial Infarction
Conditions
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.
Interventions
DEVICEDrug-coated balloon
Treatment of in suit coronary lesions with drug-coated balloon
DEVICEDrug-eluting stent
Treatment of in suit coronary lesions with drug-eluting balloon
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Restenosis rate (RR) | 12-24 months | in-stent restenosis |
| Target lesion failure (TLF) | 12-24 months | The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization |
| 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 |
Contacts
Primary ContactJiang Jun, PhD
Outcome results
None listed