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 reference vessel ≥ 2.75 mm
• Single- or multi-vessel disease with only 1 lesion meeting the definition of severe stenosis and anatomically amenable to coronary revascularization using DCB alone judged by physician.

• Severe stenosis is defined if 1 of the following criteria are met:

• visual angiographic stenosis with severity >= 70%.
• functional stenosis with quantitative flow reserve (QFR) or fractional flow reserve (FFR) < 0.8.
• The prospective subject is agreed on participating the study with a formal written consent

Exclusion criteria

• Acute myocardial infarction* (STEMI or NSTEMI) within the past one month

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

• Symptoms of myocardial ischemia
• New ischemic ECG changes
• Development of pathological Q waves
• Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
• Identification of a coronary thrombus by angiography
• Type 1 MI defined by "the Fourth Universal Definition of Myocardial Infarction (2018)", which occurred within the last one month from inclusion phase would be excluded from this study.
• Patients who have received percutaneous coronary intervention (including stent implantation, plain old balloon angioplasty, and DCB angioplasty) within 12 months on the target vessel before the index procedure.
• Currently recommended indications for DCB: in-stent restenosis, complex bifurcation lesions requiring 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 suitable for DCB treatment:

• long lesion with length >= 40mm.
• severe tortuous, or severe angulated vessels, especially when vessel recoil seems possible.
• Chronic total occlusion

• Definition: A lesion of a coronary artery becomes completely blocked for a duration of greater than or equal to 3 months based on angiographic evidence.
• lesions in left main coronary artery
• lesions in venous or arterial graft
• Chronic heart failure with left ventricular ejection fraction < 35% after 6 months of Guideline-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 and symptoms of heart failure.
• Non-cardiac Comorbidities:

• Severe liver insufficiency defined as 1 of the following:

• alanine transaminase or aspartate transaminase more than 5-fold of upper reference limit.
• Child-Pugh grade B or C.
• Severe renal insufficiency with estimated glomerular filtration rate < 30 ml/min/1.73m2.
• Malignant tumor.
• A life expectancy of less than 1 year.
• Unsuitable for coronary intervention or long-term antithrombotic therapy

• Myocardial bridging located at target lesions.
• Major bleeding (BARC type 3 to 5) or active pathological bleeding (including gastrointestinal or genitourinary bleeding) within 3 months, or major surgery within 2 months.
• Intolerable to double (aspirin plus P2Y12 inhibitor) or single (aspirin or P2Y12 inhibitor) antiplatelet therapy.
• History of intracranial hemorrhage.
• 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 months before the index procedure.
• Participants deemed unsuitable to be enrolled by investigators, such as conditions that may result in protocol nonadherence.