Intravascular Ultrasound- and Angiography-Derived Fractional Flow Reserve-Guided Drug-Coated Balloon for Large Coronary Artery De Novo Lesions

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Trial name Intravascular Ultrasound- and Angiography-Derived Fractional Flow Reserve-Guided Drug-Coated Balloon for Large Coronary Artery De Novo Lesions Objectives To compare the safety and efficacy of Drug-Coated Balloons (DCB) versus Drug-Eluting Stents (DES) in large de novo coronary lesions guided by intravascular ultrasound (IVUS) and Angiography-derived fractional flow reserve (AngioFFR). Study design Investigator-initiated, open-label, multicenter, non-inferiority randomized controlled trial Patient enrollment 2,492 patients enrolled in China and Republic of Korea. Duration Anticipated recruitment is 2 years. Follow-up will be performed at 1, 3, 6, 12, 36, and 60 months. Inclusion Criteria 1. Patients must require PCI based on clinical condition (angiographic stenosis ≥ 75% or angiographic stenosis ≥ 50% with AngioFFR≤0.80) and have signed the informed consent form. 2. Coronary angiography shows a single non-left main lesion, with a reference vessel diameter between 2.75mm and 4.00mm, and an estimated lesion length \< 40mm. 3. Following adequate intraoperative lesion preparation, the following must be met: IVUS shows MLA≥ 4.0mm² and/or AnioFFR \> 0.80. 4. Absence of flow-limiting dissection or hematoma (angiographic Type A or B dissection; IVUS dissection not involving the media) and TIMI flow grade 3 5. Patients must be able to be followed up for more than 1 year and be willing to cooperate with the trial follow-up requirements. Exclusion Criteria 1. Patients are younger than 19 or older than 80 years of age. 2. High-Risk Clinical/Anatomical Factors: Cardiogenic shock, left main disease, severely tortuous lesions, complex bifurcation lesions, severe calcification, total occlusion of the target vessel, or bypass grafts. 3. Recent major surgery (within 1 month pre-procedure) or clear gastrointestinal bleeding events. 4. Known allergy or contraindication to heparin, aspirin, clopidogrel, prasugrel, ticagrelor, or contrast media (patients with clear contrast allergies such as rash may be included if controlled beforehand with effective medication like glucocorticoids or diphenhydramine). 5. Women who are currently pregnant or breastfeeding. 6. Non-cardiac comorbidities indicating an expected life expectancy of less than 1 year. 7. Any other factors that may affect follow-up or participation in other clinical studies. Patient follow-up Clinical follow-up will perform 1, 6, 12, 36 and 60 months after the procedure by telephone contacts or office visits. Primary endpoint The study employs a hierarchical testing (sequential testing) approach, following the logical order below: 1.12-Month Net Adverse Clinical Events (NACE): Defined as a composite endpoint consisting of all-cause death, stroke, myocardial infarction (MI), ischemia-driven revascularization, and bleeding (BARC 3 or 5). 2.Ischemic Endpoint - Major Adverse Cardiac and Cerebrovascular Events (MACCE): Defined as the composite of death, MI, ischemia-driven revascularization, and ischemic stroke. 3.Bleeding Endpoint: Defined as 12-month major bleeding or clinically relevant non-major bleeding, categorized as BARC 2, 3, or 5. Secondary endpoint 1. Target Vessel Failure (TVF): A composite of cardiac death, target vessel MI, or target vessel revascularization. 2. NACE, major bleeding or clinically relevant non-major bleeding, and MACCE at 36 and 60 months. 3. All-cause death and cardiac death. 4. MI, spontaneous MI, peri-procedural MI, and target vessel MI. 5. Any revascularization of the target vessel/target lesion. 6. Any revascularization of a non-target vessel/ non-target lesion. 7. Any revascularization (ischemia-driven or all-cause). 8. Stent Thrombosis: Classified as definite, probable, or possible. 9. Stroke: Including both ischemic and hemorrhagic stroke. 10. Bleeding Events: BARC 3 or 5 bleeding, and BARC 2 bleeding. 11. Evaluation of cost-effectiveness.

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