Coronary heart disease
Conditions
Interventions
Group A:only use drug eluting balloon in main branch
Group B:stenting in main branch
Sponsors
Union Hospital Affiliated to Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-80 years; 2. Patients with stable angina pectoris, unstable angina pectoris, or acute non-ST elevation myocardial infarction; 3. De novo TBLs (Medina type: 0,1,1; 1,1,1; 1,0,1); diameter of main branch vessel >= 2.5mm, side branch vessel diameter >= 2.25mm; 4. The anatomy and features of bifurcation lesions are suitable for PCI treatment, including balloon angioplasty or stenting; 5. Voluntary accept all follow-up assessments required by the protocol; 6. The subject (or legal guardian) understood the study requirements and treatment procedures and signed a written informed consent prior to performing any examination or procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Left main coronary bifurcation lesion; 2. Anatomic/lesion features are not suitable for PCI or have been defined complex bifurcation lesion according to definition criteria; 3. In-stent restenosis and bifurcation lesions; 4. Those who do not tolerate dual antiplatelet therapy; 5. Patients with obvious hematopoietic abnormalities, such as platelets 700 x 10^9/L, white blood cells 5 times the upper normal limit) or renal insufficiency (eGRF = grade 3), etc.; 8. Life expectancy <= 12 months of serious disease, such as cancer, other advanced diseases; 9. Pregnant women or those planned for pregnancy; 10. Subjects are allergic or contraindicated to concomitant drugs required by the stent system or protocol for study, such as stent-coated drugs, stainless steel or alloy, aspirin, thienopyridines, contrast agent, etc.; 11. Those who are participating in the clinical trial of another drug or device and have not reached the primary endpoint, or plan to participate in the clinical trial of another drug or device within 12 months after procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion failure (TLF) within 1 month after procedure;Late luminal loss (LLL) within the segment of the primary branch lesion at 12 months after procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion failure (TLF) in the 12-month after procedure;cardiac death;Target vascular myocardial infarction (TVMI);Ischemic-driven target lesion/vascular revascularization (TLR/TVR);Target vascular thrombosis (TVT, acute, subacute, advanced, extremely advanced thrombosis);Intraoperative acute vascular occlusion, acute myocardial infarction;Release of myocardial necrosis markers associated with interventional procedure;Late luminal loss within the side 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
Union Hospital Affiliated to Fujian Medical University
Outcome results
None listed