Bingo drug-eluting balloon versus a drug-eluting stent for coronary bifurcation lesions: a prospective, multi-center, randomized, non-inferiority trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
Treat the main vessel and side branch of bifurcation lesion with drug-eluting balloon
Treat the main vessel of bifurcation lesion with drug-eluting stent, and treat the side branch with uncoated balloon or drug-eluting stent
in-segment late lumen loss in main branch
use quantitative coronary angiography by an independent core laboratory
Time frame: 9 months
Procedure success rates
include device success, lesion success and clinical success
Time frame: up to 7 days in-hospital
Minimal lumen diameter
use quantitative coronary angiography by an independent core laboratory
Time frame: 9 months
Diameter stenosis
use quantitative coronary angiography by an independent core laboratory
Time frame: 9 months
Dissection and type
use quantitative coronary angiography by an independent core laboratory
Time frame: 9 months
in-segment late lumen loss in side branch
use quantitative coronary angiography by an independent core laboratory
Time frame: 9 months
Binary restenosis
use quantitative coronary angiography by an independent core laboratory
Time frame: 9 months
Target lesion failure
include cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization
Time frame: 1, 6, 9 and 12 months
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Target lesion thrombosis
include acute, sub-acute, late and very late period
Time frame: 1, 6, 9 and 12 months
BARC bleeds
type 2, 3 or 5
Time frame: 1, 6, 9 and 12 months
Stroke
any stroke
Time frame: 1, 6, 9 and 12 months
Myocardial infarction
include peri-operation and 12 months
Time frame: Peri-operation and 12 months
Death
include cardiac and all-cause death
Time frame: 1, 6, 9 and 12 months
Major Adverse Cardiovascular Events
composite endpoint with death, myocardial infarction and target vessel revascularization
Time frame: 1, 6, 9 and 12 months