Coronary heart disease
Conditions
Interventions
PSS+SB-DEBA group:Drug eluting stent implantation in main branch and later drug eluting balloon dilatation in side branch
SDS gourp:Systematic dual stenting technique
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects = 18 years old; 2. Asymptomatic myocardial ischemia, stable/unstable angina, or acute myocardial infarction (chest pain attack to hospitalization>7 days); 3. Primary left main coronary bifurcation lesion(LMCBL) (Medina classification is 0,1,1; 1,1,1) and vascular anatomy and pathological features are suitable for PCI; 4. Visual examination of baseline angiography: main vessel and side branch reference vessel diameter = 2.5 mm, diameter stenosis rate = 70%; 5. The subject (or legal guardian) understands the trial design and treatment procedure, and provides written formal consent before any specific trial or operation; 6. The subject is willing to comply with the follow-up evaluation of all protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Anatomical/pathological characteristics of bifurcation lesions are not suitable for PCI; 2. Chronic occlusive disease (CTO) and severe calcification exist in bifurcation lesions; 3. In stent restenosis bifurcation lesions; 4. Those who cannot tolerate dual antiplatelet therapy; 5. Active bleeding or obvious bleeding tendency; 6. Suffering from serious diseases with life expectancy = 12 months, such as cancer, other late diseases, etc; 7. Pregnant women or those planning pregnancy; 8. Subjects are allergic to or have contraindications to concomitant drugs required by the stent system or protocol used in the study; 9. Subject is participating in the clinical trial of another drug or device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion failure (TLF) at 12 months after procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion failure (TLF) within 1 month after procedure;Incidence of side branch blood flow limiting dissection salvage stent implantation;The incidence of composite endpoint of target lesion failure (TLF) and each component;Target vessel thrombosis;Intraoperative acute vascular occlusion, acute myocardial infarction;Release of myocardial necrosis markers associated with interventional procedure;Late luminal loss within the SB branch lesion segment at 12 months after procedure;The incidence of target lesion restenosis at 12 months after procedure; | — |
Countries
China
Contacts
Public ContactChen Lianglong
Fujian Medical University Union Hospital
Outcome results
None listed