coronary artery disease
Conditions
Interventions
Drug-coated balloon group:NA
two-stent group:NA
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Clinical criteria: a. Aged 18-80 years old; b. The lesion is suitable for intervention; c. There are evidence of unsymptomatic myocardial ischemia, stable or unstable angina pectoris, and stable myocardial infarction (occurring more than 7 days before enrollment, including non-ST-segment elevation myocardial infarction and ST-segment elevation myocardial infarction); d. Subjects who can understand all the risks and benefits described in the informed consent document, voluntarily participate in this study, sign a written informed consent, and can receive follow-up. Imaging criteria: a. Angiography showed that the target lesion was de novo and true bifurcation lesions (Medina 1,1,1/0,1,1/1,0,1); c. Coronary stenosis of the target lesion is = 50%.
Exclusion criteria
Exclusion criteria: Clinical criteria: a. Myocardial infarction occured within one week before enrollment; c. Stroke occurred within 6 months before enrollment, excluding transient ischemic attack (TIA) and lacunar infarction; c. Patients who have a clear bleeding tendency, a history of intracerebral hemorrhage or subarachnoid hemorrhage within 6 months, a history of active gastrointestinal ulcer bleeding, and contraindications of antiplatelet and anticoagulant drugs, and are unable to undergo anticoagulant treatment; d. Allergies to drug-eluting stent, drug-coated balloon or relevant drugs required by the study; e. The expected life expectancy is less than 1 year or who is difficult to complete 12 months of follow-up; f. Pregnant, lactating women, patients with fertility plan, or patients who are unable to take adequate contraception measures during the study period; g. Those who are participating in clinical trials and have not reached the primary endpoint; h. Patients who the researcher thinks are not suitable for selection for other reasons. Imaging criteria: a. Patients with untreated chronic total obstructive disease; b. Patients with severe calcification of the target lesion in the branch vessel and unable to perform pre-expand or kissing balloon inflation; c. Stent restenosis lesions; d. Patients experienced dissection( =grade C) or restenosis(>50%) after side branch target lesions pre-dilation and kissing balloon inflation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side branch stenosis of target lesion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative complications;Cardiovascular adverse events;late lumen loss; | — |
Countries
China
Contacts
Public ContactYong Chen
West China Hospital, Sichuan University
Outcome results
None listed