TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention

This study will compare the effectiveness of the TRADENT™ coronary scoring balloon with a conventional non-scoring balloon for lesion preparation in patients undergoing a drug-coated balloon (DCB)-first percutaneous coronary intervention (PCI) strategy for de novo coronary lesions. The study will evaluate angiographic acute gain after lesion preparation and assess whether improved lesion preparation leads to a higher rate of successful drug-coated balloon (DCB)-alone treatment. The study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial.

Inclusion Criteria: 1. Age ≥19 years and able to provide written informed consent. 2. Patients with stable coronary artery disease or non-ST-segment elevation acute coronary syndrome (NSTE-ACS) requiring percutaneous coronary intervention (PCI). 3. Patients for whom the operator has planned and documented a drug-coated balloon (DCB)-first strategy with the intention of achieving drug-coated balloon (DCB)-alone treatment of the index lesion before randomization. Drug-eluting stent (DES) may be used if lesion preparation is inadequate or required for patient safety. 4. Native coronary de novo lesion with visually estimated diameter stenosis (DS) ≥50% and ≤100%. 5. A target lesion for which a study balloon suitable for a balloon-to-artery ratio of 1.0 (1:1) based on the visually estimated reference vessel diameter (RVD) can be selected in either treatment group. 6. Successful guidewire crossing of the target lesion, with no predilatation of the target lesion before randomization. 7. Ability to designate one target lesion per participant. Exclusion Criteria: 1. ST-segment elevation myocardial infarction (STEMI), cardiogenic shock, or ongoing hemodynamic instability within 72 hours before index percutaneous coronary intervention (PCI). 2. Unprotected left main coronary artery disease or saphenous vein graft lesion. 3. Substantial thrombus burden in the target lesion. 4. Balloon dilatation or other plaque-modification treatment of the target lesion before randomization. 5. Uncontrolled contraindication to the study drug, contrast media, or any component of the study device. 6. Pregnancy or breastfeeding. 7. Life expectancy \