STrategies of scheduled drug-coated balloons (DCB) versus conventional DES for the interveNTional therapy of de novo lesions in large coronary vESSels (STENTLESS) trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. visual angiographic stenosis with severity \>= 70%. 2. 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: 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 wall motion abnormality in a pattern consistent with an ischemic etiology 5. 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: 1. long lesion with length \>= 40mm. 2. severe tortuous, or severe angulated vessels, especially when vessel recoil seems possible. 3. 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. 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 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: 1. 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. 2. Severe renal insufficiency with estimated glomerular filtration rate \< 30 ml/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 3 to 5) or active pathological bleeding (including gastrointestinal or genitourinary bleeding) within 3 months, or major surgery within 2 months. 3. Intolerable to double (aspirin plus P2Y12 inhibitor) or single (aspirin or P2Y12 inhibitor) antiplatelet therapy. 4. History of intracranial hemorrhage. 5. 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.