To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,548
A total of 774 subjects meeting the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Biolimus-Coated Coronary Artery Balloon Dilatation Catheter.
A total of 774 eligible subjects who met the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Excrossal™ Xinyue Drug-Coated Stent System.
Primary endpoint
The primary endpoint of target lesion failure (TLF) at 1 year post-operation was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR).
Time frame: Day of procedure (treatment day), 7 days post-procedure or discharge day, 30 days post-procedure, 6 months post-procedure, 9 months post-procedure, and 1 year post-procedure.
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