The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions

Inclusion Criteria: Subjects that participate in this study must fulfill all the following criteria: General inclusion criteria: 1. Age from 18 to 80 years old, man or non-pregnant woman; 2. Subjects with stable or unstable angina, old myocardial infarction, or asymptomatic ischemic evidence with clinical diagnosis; 3. Subjects without contraindications of coronary artery bypass grafting (CABG); 4. Subjects must agree to the follow up of angiographic and clinical required in the study; 5. Subjects are able to understand the purpose of this study, provide an informed consent to show recognize to the study protocol. Angiographic inclusion criteria: 1. One or two bifurcation lesions, locate in different epicardial vessels, the bifurcation lesion in each epicardial vessel can not over 1; or 1 de nove coronary artery bifurcation can be included after 1 lesion of non-target vessel has been successfully treated by PCI (Percutaneous Coronary Intervention); 2. Residual diameter stenosis in main branch (MB) ≥ 70% (visually), or ≥ 50% simultaneously with clinical symptom, and the diameter stenosis in side branch (SB) ≥ 50% (visually); and the main branch's residual stenosis ≤ 20% with TIMI 3 flow post the stent placement, while the side branch diameter stenosis ≥ 70% post the MB stenting; 3. Fulfill the definition of truly bifurcation lesions by Medina type (1.1.1、1.0.1、0.1.1); 4. Diameter in side branch between ≥ 2.5 mm to ≤ 4.00 mm (visually) and lesion length ≤ 26 mm (visually); 5. Each side branch of the bifurcation lesion can be treated by only 1 study drug coated balloon (DCB) or control DCB, and the lesion shall be fully covered by the DCB ( the distal end of the balloon shall exceed the lesion at least 1 mm). Exclusion Criteria: If subjects fulfill any of below criteria, this subject shall be exclude from this study. General exclusion criteria: 1. Pregnant or lactating women 2. Any newly myocardial infarction onset within 1 week or, the myocardial enzyme of CK (Creatine Kinase) or CK-MB does not return to normal level after any myocardial infarction; 3. Cardiogenic shock; 4. Severe chronic heart failure, NYHA (New York Heart Association) ≥ grade III, or left ventricular ejection fraction \< 35% (accessed by echocardiography or left ventricular angiography) 5. Patients with renal insufficiency (estimated glomerular filtration rate \< 30ml/min/1.73m2 calculated by MRDR (Modification of Diet in Renal Disease) formula or subject is receiving renal dialysis) 6. Having a history of hemorrhagic diseases such as cerebral hemorrhage, gastrointestinal hemorrhage; stroke occurring or any situation occurring that may lead to prolongation of anticoagulation therapy within 6 months before operation; 7. History of coronary or peripheral vascular interventional therapy within 12 months before hospitalized. 8. Patients are allergic or contraindicate to contrast agent, paclitaxel, heparin, antiplatelet and anticoagulant drug; 9. The Subjects have other serious diseases and the expected survival is less than 12 months; 10. Investigators determine the subjects' compliance is poor, cannot complete the study as required; Angiographic exclusion criteria 1. Main branch lesion or non-target lesion(s) located in left main; 2. Main branch lesion or non-target lesion(s) is triple vessel lesion, all need to be treated; 3. Side branch lesion is triple bifurcation or multiple bifurcation; 4. Main branch lesion located within 3 mm of the origin of the LAD (Left Anterior Descending), LCX (Left Circumflex Branch) or RCA (Right Coronary Arter); 5. Side branch target lesion is diffusion lesion and length \> 26mm; or a ≥90% stenosis lesion is found near the SB lesion within 5 mm; 6. Side branch as the target vessel has received any interventional treatment; 7. Side branch as the target lesion or target vessel involve in aneurysm; 8. The lesion in side branch or main branch is total occlusive lesions, with TIMI blood flow of grade 0; 9. Side branch target lesion is moderate or heavy calcified or target vessel excessive tortuosity, which is unfavorable for interventional treatment anatomically; 10. Subject's blood pressure is too low to be injected with nitroglycerin ≥ 100 ug, this subject can not be included in the study; 11. Side branch target lesion can not reach the following outcomes, after the completely balloon pre-dilatation: 1\) Residual stenosis (DS %) is ≤50% (visually); 2) TIMI Grade-3 flow ((visually); 3) No angiographic complications (e.g., no-reflow, distal embolization, side branch closure) 4) No dissections NHLBI grade C-F;