Patients with de novo left main coronary artery bifurcation lesions undergoing interventional treatment (including any bifurcation type)
Conditions
Interventions
DES-only Group:underwent Implantation with Drug-Eluting Stent-only
DCB Group:Standalone drug-coated balloon (DCB) angioplasty or hybrid procedures combining DCBs and drug-eluting stents (DES).
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Objective evidence of myocardial ischemia, or stable/unstable angina, or acute myocardial infarction occurring >1 week prior; 3. Coronary angiography confirms a de novo left main (LM) bifurcation lesion—defined as distal LM involvement of the left anterior descending and/or left circumflex ostium, any Medina classification—and the investigator deems it suitable for percutaneous coronary intervention; 4. Target-side-branch vessel (main branch, typically the LCX or a large diagonal/intermediate branch) reference vessel diameter (RVD) >= 2.5 mm by visual estimate or QCA; 5. If the target lesion’s main vessel or major side branch contains a chronic total occlusion (CTO), it must have been successfully recanalized (TIMI flow >= grade 2) before randomization; 6. The patient is willing and able to complete all follow-up visits required by the protocol, including the mandatory 1-year angiographic follow-up; 7. The patient (or legally authorized guardian) has fully understood the study information and voluntarily provided written informed consent before any protocol-related procedure is performed;
Exclusion criteria
Exclusion criteria: 1. STEMI occurring within 1 week before enrolment; 2. Target lesion is left-main in-stent restenosis (ISR) or a bypass-graft lesion; 3. Hemodynamic instability or cardiogenic shock; 4. Left-ventricular ejection fraction (LVEF) < 30 %; 5. CTO of the target-lesion main vessel or major side branch that could not be successfully recanalized; 6. Concurrent participation in another interventional clinical trial whose primary-endpoint follow-up is not yet complete; 7. Known hypersensitivity to any study-device component (DCB, DES, IVUS catheter), coating drug (e.g., paclitaxel, sirolimus analogues), polymer, or required concomitant medications (aspirin, P2Y12 inhibitor, heparin, contrast media, etc.); 8. Contraindication preventing = 12 months of dual antiplatelet therapy (DAPT); 9. Life expectancy < 12 months from non-cardiovascular causes; 10. Pregnant or lactating women, or women planning pregnancy during the study period; 11. Any other condition that, in the investigator’s opinion, renders the patient unsuitable for participation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Patient-Reported Outcome (PRO) scores;Clinical event rate;Procedural success rate;Immediate post-procedure IVUS findings;Quantitative coronary angiography (QCA);Quantitative Flow Ratio (QFR); | — |
Countries
China
Contacts
Public ContactChunguang Qiu
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed