To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75\~4.0mm).
Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions.
Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions.
Target lesion failure
A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization
Time frame: 12 months follow-up
Procedural success
Consisting of device success ( after successful delivery of the study balloon, the visual residual stenosis of the target lesion is less than 50%, TIMI level 3 blood flow ) , Lesion success (defined as the proportion of the target lesions in which the final stenosis is \<20% after treatment with any other adjunctive therapy ) , Clinical success ( Defined as no major adverse cardiac events caused by ischemia during the subject's hospitalization).
Time frame: During the hospital stay, up to 7 days after PCI
Target lesion failure
A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization
Time frame: 1 month, 6months follow-up
Patient-oriented composite endpoint
A composite of all-cause mortality, myocardial infarction, and any revascularization
Time frame: 1 month, 6months,12 months follow-up
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