A Trial of DCB vs DES in the Treatment of de Novo Large Diameter Coronary Atherosclerotic Stenosis(LARGE ONE)

Inclusion Criteria: CI1. Age of subject 18-75 years old; CI2. The subject (or legal guardian) understands and provides written informed consent tothe test requirements and treatment procedures prior to performing any specific tests orprocedures in the study; CI3. The subject is suitable for percutaneous coronary intervention (PCI); CI4. The subject had symptomatic coronary artery disease with objective evidence orasymptomatic ischemia; CI5. Subject is willing to submit to all subsequent evaluations required by the testprotocol Angiogragh Inclusion AI1. At Maximum 2 target lesions with stenosis ≥50%, located in no more than 2 vessels witha visual reference vessel diameter (RVD) of ≥3.00 mm and ≤4.00 mm; AI2. The length of the target lesion must be≤35 mm (visually) and can be covered by onestudy stent or drug balloon; AI3. The first target lesion must be successfully predilated/pretreated without:

1. Vascular tears affecting hemodynamics (TIMI blood grade ≤2);
2. Coronary dissection classified as D, E and F(ARC);
3. Residual stenosis > 30% after lesion preparation; Note: If Type C dissection occurs at lesion predilation/preparation, clinical investigatorswill determine whether the target lesion can be included based on the comprehensivesituation of blood flow and patients risks . Type C dissection will be excluded from theOCT subgroup considering the risk of dissection extension for OCT operation. AI4. The anatomical conditions of the coronary artery were appropriate, and the studyinstrument could be transported to the appropriate location of the target lesion.

Exclusion Criteria: CE1. Subjects with clinical symptoms and/or ECG findings consistent with the diagnosis ofacute ST-segment elevation myocardial infarction (STEMI) within 7 days; CE2. Subject is known to be allergic to contrast agents (which cannot be fully pretreated)and/or concomitant medications required by the stent system or protocol (e.g.,cobalt-chrome, platinum-chrome, stainless steel, rapamycin, paclitaxel and similarconfiguration compounds, drug coating carrier components, all P2Y12 receptor inhibitors,aspirin, etc.); CE3. Planned surgical treatment within 6 months after baseline surgery; CE4. Severe heart failure (NYHA Grade IV) or left ventricular ejection fraction <30% (ultrasound or left ventricular contrast); CE5. Previous renal impairment: serum creatinine >2.0mg/dL; Or on dialysis; CE6. Previous bleeding events (BARC III or V); CE7. Subject is receiving or indication of long-term anticoagulant therapy ; CE8. Subject has any of the following conditions (baseline assessment) :

• Other serious medical conditions that reduce subjects' life expectancy to less than 13months (e.g., cancer, congestive heart failure);
• Subject has a current substance abuse problem (e.g., alcohol, cocaine, heroin, etc.);
• Subject plans to undergo surgical/intervention procedures that may result innon-compliance with protocol or confusing data interpretation; CE9. Subject has a history of bleeding tendency, coagulation disorders or refusal of bloodtransfusion; CE10. The subject is participating in a clinical trial of another investigational drug ordevice that does not meet its primary endpoint; CE11. Subjects are scheduled to participate in another investigational drug or deviceclinical trial within 13 months of baseline procedure; CE12. Subjects who intend to be pregnant within 13 months of baseline procedure (fertileand sexually active women should consent to use a reliable contraceptive method fromscreening to 13 months after baseline surgery); CE13. Subjects are pregnant or breastfeeding (fertile women with pregnancy possibilityshould undergo a pregnancy test within 7 days prior to baseline surgery). Angiogragh Exclusion AE1. Plan to treat 3 or more target lesions; AE2. Plan to treat more than 2 major epicardial vessels; AE3. A single lesion to be treated cannot be covered by a single stent or a single drugballoon; AE4. The subject had two target lesions in the same target vessel, and the distance betweenthe two target lesions was ≤15mm (visual observation); AE5. Target lesions were located in the left main trunk; AE6. Target lesions were located within 3mm of the initial segment of the left anteriordescending artery (LAD) or left circumflex artery (LCX). AE7. Target lesions were located in a saphenous vein, artery or artificial bypass graft; AE8. Target lesions need to be treated through a saphenous vein, artery or artificialbypass graft ; AE9. Target lesion blood flow grade of TIMI 0/1 before guide wire passes through ; AE10. Treatment of target lesions involves multi-stent strategy in complex lesions (e.g.,bifurcated lesions require more than one stent); AE11. Target lesions involve previously in-stent restenosis lesions or overlap withpreviously implanted stents; AE12. Subject has unprotected left main coronary artery disease (>50% diameter stenosis); AE13. Subjects have received PCI for any type of target lesion (e.g., balloon dilation,stent placement, balloon dissection, etc.) within 12 months before baseline; AE14. Presence of thrombus or possible thrombus in the target lesion (visual); AE15. The target lesions were moderate to severe calcification lesions.