Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

Inclusion Criteria:

• Patient-related:

1. Patient must be ≥ 18 years of age

2. Patient is able to verbally confirm understanding of the study aim, risks,benefits, and treatment alternatives of receiving DCB or DES and he/she orhis/her legally authorized representative provides written informed consentprior to any study-related procedure

3. (i) Clinical evidence of angina, and/or (ii) an abnormal functional studydemonstrating myocardial ischemia due to the target lesion(s), or (iii) acutecoronary syndrome [unstable angina or non-ST-elevation myocardial infarction (NSTEMI) or uneventful STEMI (≥ 48 hours after primary PCI and no sign ofthrombus in lesion(s) to treat)]

4. Patient with lesions suitable for PCI with a DCB (and/or DES) according to theInstructions for Use

5. Patient is able to comply with the study protocol and agrees to undergo theclinical follow-up of 30 days, 6 months, 12 months, 24 months, and 36 months

• Lesion-related:

1. Presence of significant de novo large vessel coronary artery disease (referencevessel diameter ≥3.0 mm by visual estimation) with either ≥ 70% diameterstenosis or intermediate ≥ 50% to <70% diameter stenosis with abnormalfunctional test or symptom of ischemia

2. Successful lesion preparation. For randomisation, the lesion must satisfy thefollowing criteria after optimal balloon angioplasty: no flow-limitingdissection (TIMI=3), and residual stenosis is ≤ 30%

• Multivessel disease with two or more vessels showing diameter stenosis of 50% ormore is not an exclusion as long as it fulfills all study's eligibility criteria.

• In diffuse lesion, inclusion is possible if the proximal reference vessel diameteris 3.0 mm or more.

Exclusion Criteria:

• Patient-related:

1. Intolerance or allergy to Paclitaxel and/or the delivery matrix (mainingredient: Iopromide)

2. Severe allergy to contrast media

3. Recent STEMI (ongoing or < 48 hours after primary PCI and/or has sign ofthrombus in lesion(s) to treat)

4. NSTEMI hemodynamically unstable

5. Known left ventricular ejection fraction of <30%

6. Inability to take dual antiplatelet therapy or anticoagulation, or singleantiplatelet therapy for at least six months

7. Non-cardiac co-morbid conditions that may result in protocol non-compliance andinability of patient to complete the study (per the site investigator's medicaljudgment)

8. Patient with concomitant medical illnesses that require cytostatic, radiationtherapy or renal replacement therapy

9. Patient who is currently/ planning to participate in another clinical trialwhen such participation could confound the treatment or outcomes of this study,except for observational registry

10. Pregnancy or lactation

11. Patient under administrative or judicial custody

• Lesion-related:

1. Small vessel disease, defined as <3.0 mm of reference vessel diameter by visualestimation

2. In-stent restenosis lesions for study lesions

3. Patient will be excluded if meet any of the following angiographic exclusioncriteria after lesion preparation: (i) Flow limiting dissection with TIMI flow < III (ii) Residual diameterstenosis >30%

• The case of persistent ischemic symptoms/signs is up to the operator'sdecision

4. Lesions which are untreatable with PCI or other interventional techniques andcoronary artery spasm in the absence of a significant stenosis

5. Left main disease or aorta-ostial lesion requiring revascularization

6. Severely calcified or tortuous vessels precluding DCB or DES application

7. Prior Coronary Artery Bypass Graft (CABG)