OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
254
DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography
The Second Hospital of Jilin University
Changchun, Jilin, China
the Second hospital of Jilin University
Changchun, Jilin, China
late lumen loss (LLL)
late lumen loss between DCB treated group and DES treated group evaluated by quantitative coronary analysis in patients with CHD
Time frame: Follow-up coronary angiography at 12 months after the procedure
The incidence rate of device-related ischemic events
The incidence rate of device-related ischemic events including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization between DCB treated group and DES treated group
Time frame: Clinical follow up at 30 days, 3,6, 9 and 12 months after the procedure
The incidence rate of patient-related ischemic events
TThe incidence rate of patient-related ischemic events including all myocardial infarction , any revascularization and all-cause death between DCB treated group and DES treated group
Time frame: Clinical follow up at 30 days, 3,6, 9 and 12 months after the procedure
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