Status:
UNKNOWN
Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
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 fi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT04072081
Start Date
September 30 2019
End Date
June 30 2021
Last Update
August 28 2019
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