STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial

Inclusion Criteria:

• Age ≥18 years
• De novo lesions of large coronary vessels with the diameter of target lesion referencevessel > 2.75 mm
• Single- or multi-vessel disease with only 1 lesion meeting the definition of severestenosis and anatomically amenable to coronary revascularization using DCB alonejudged by physician.
• Severe stenosis is defined if 1 of the following criteria are met:

1. visual angiographic stenosis with severity >= 70%.
2. functional stenosis with quantitative flow reserve (QFR) or fractional flowreserve (FFR) < 0.8.

• Other coronary artery lesions are not recommended for coronary revascularization bycurrent guidelines and are not likely need to be treated within the next 1 year judgedby physician (e.g., visual stenosis with severity between 50-70% and FFR > 0.8)
• The prospective subject is agreed on participating the study with a formal writtenconsent

Exclusion Criteria:

• History of acute coronary syndrome within the last 6 months.
• Acute coronary syndrome is defined as 1 of following diagnosis:

1. Unstable Angina Pectoris (UAP)
2. ST-Elevated Myocardial Infarction (STEMI)
3. Non-ST-Elevated Myocardial Infarction (NSTEMI)

• Diagnosis of myocardial infarction (MI) requires both clinical evidence ofmyocardial ischemia and elevation of cardiac Troponin (cTn) I or T values with atleast 1 value above the 99th percentile upper normal range limit (URL)
• Clinical evidence of myocardial ischemia is defined as 1 of the following:

1. Symptoms of myocardial ischemia
2. New ischemic ECG changes
3. Development of pathological Q waves
4. Imaging evidence of new loss of viable myocardium or new regional wallmotion abnormality in a pattern consistent with an ischemic etiology
5. Identification of a coronary thrombus by angiography

• All types of MI (type 1 to 5 MI) defined by "the Fourth Universal Definition ofMyocardial Infarction (2018)", which occurred within the last 6 months frominclusion phase would be excluded from this study.
• Patients who have received percutaneous coronary intervention (including stentimplantation, plain old balloon angioplasty, and DCB angioplasty) within 12 monthsbefore the index procedure.
• Currently recommended indications for DCB: in-stent restenosis, bifurcation lesionsrequiring concomitant intervention of the major vessel and its adjacent side branch (e.g., lesions requiring dual stent implantation, kissing balloon technique, etc.)
• Lesions with any of the following anatomical characteristics presumably not suitablefor DCB treatment:

1. long lesion with length >= 40mm.
2. severely calcified, moderate or severe tortuous, or severe angulated vessels,especially when vessel recoil seems possible.

• Moderate tortuosity: 2 bends >75° or 1 bend >90° to reach the target lesion.
• Severe tortuosity: 2 bends >90° or 3 bends >75° to reach the target lesion.
• Severe angulation: angulated segment > 90°
• Severe calcification: radiopacities noted without cardiac motion beforecontrast injection generally compromising both sides of the arterial lumen

3. Chronic total occlusion

• Definition: A lesion of a coronary artery becomes completely blocked for aduration of greater than or equal to 3 months based on angiographicevidence.

4. lesions in left main coronary artery
5. lesions in venous or arterial graft

• Chronic heart failure with left ventricular ejection fraction < 35% after 6 months ofGuideline-Directed Medical Treatment (GDMT)
• Acute heart failure, hemodynamic instability, or cardiogenic shock
• Acute heart failure is defined as a rapid onset of new or worsening signs andsymptoms of heart failure.
• Non-cardiac Comorbidities:

1. Severe liver insufficiency defined as 1 of the following:

• alanine transaminase or aspartate transaminase more than 5-fold of upperreference limit.
• Child-Pugh grade B or C.

2. Severe renal insufficiency with estimated glomerular filtration rate < 30ml/min/1.73m2.
3. Malignant tumor.
4. A life expectancy of less than 1 year.

• Unsuitable for coronary intervention or long-term antithrombotic therapy

1. Myocardial bridging located at target lesions.
2. Major bleeding (BARC type 2 to 5) or active pathological bleeding (includinggastrointestinal or genitourinary bleeding) within 3 months,or major surgerywithin 2 months.
3. Open surgery is planned within six months after discharge.
4. Intolerable to double (aspirin plus P2Y12 inhibitor) or single (aspirin or P2Y12inhibitor) antiplatelet therapy.
5. History of intracranial hemorrhage.
6. Pregnant women, lactating women, and women of childbearing potential.

• History of artificial valve replacement.
• History of participating in any other clinical studies or trials within 12 monthsbefore the index procedure.
• Participants deemed unsuitable to be enrolled by investigators, such as conditionsthat may result in protocol nonadherence.