Coronary Bifurcation Disease
Conditions
Interventions
Experimental group:Smartbird Drug-Coated Balloon
Control group:BingoTM drug-eluting balloon
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Stable or unstable angina, or stable recent myocardial infarction (occurring more than 7 days before enrollment, including non-ST-elevation and ST-elevation myocardial infarction), or evidence of asymptomatic local myocardial ischemia; 3. Suitable for balloon dilatation angioplasty or stent implantation; 4. Adequately comply with the research protocol and agree to be followed up for 30 days post-procedure, 6, 9, and 12 months post-procedure, of which angiography is required at 9 months; 5. Volunteer to participate in this study, understand all the risks and benefits described in the informed consent document, and sign a written informed consent form; 6. The angiography shows that the target lesion is a bifurcation lesion and de novo lesion; 7. The stenosis degree of the branch vessel opening of the target lesion is >=70%; 8. The main branch vessel is suitable for PCI and stent treatment. Double stents are not considered and a simple kissing balloon dilation is proposed; 9. The diameter of branch vessels is between 2.0-4.0 mm, and the length of the lesion is <=35mm.
Exclusion criteria
Exclusion criteria: 1. Renal insufficiency (eGFR50% after double balloon kissing dilation; 17. Pregnant or lactating women, or women of childbearing age who have a family plan or cannot take adequate contraceptive measures during the study period; 18. Those who are participating in clinical trials of other drugs or devices and have not reached the primary endpoint; 19. Researchers for other reasons think it is not suitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stenosis degree of lumen diameter of target lesion branch vessel (%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Catheter pushing capability;Balloon retractability;Catheter withdrawal capability;Interventional therapy success rate;The Incidence of target vascular restenosis;Late lumen loss in segmental branch vascular disease of target lesions;target lesionrevascularization,TLR;target vessel revascularization;Target Lesion Failure, TLF;The Incidence of major cardiovascular adverse events;The incidence of major cardiovascular and cerebrovascular events (MACCE);Identified thrombus and possible thrombus;All adverse events and serious adverse events (AEs/SAEs); | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital, Fudan University
Outcome results
None listed