STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
This is a multicenter, open-label, randomized controlled study meant to compare the safety and efficacy of scheduled drug-coated balloon (DCB) and conventional drug-eluting stent (DES) strategy in the treatment of de novo lesions of large coronary vessel with diameter larger than 2.75 mm. The trial was designed to provide high-quality evidence for expanding the clinical indications of DCB, and to explore a better way for coronary intervention based on DCB.
• 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.
• Other coronary artery lesions are not recommended for coronary revascularization by current guidelines and are not likely need to be treated within the next 1 year judged by 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 written consent