RECRUITINGINTERVENTIONAL

Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions

About This Trial

This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).

Who May Be Eligible (Plain English)

Inclusion Criteria 1. Subject must be at least 19 years of age 2. Subject who is able to understand risks, benefits and treatment alternatives and sign willing to sign a consent form voluntarily 3. Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥3.0 mm Exclusion Criteria 1. Patients unable to provide consent 2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents 3. Patients with angiographic findings of 1) Left main coronary artery disease 2) In-stent restenosis is the cause of target lesion 3) Target lesion in bypass graft 4) True bifurcation lesion that requires upfront 2-stenting 4. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year 5. Patients who may result in protocol non-compliance (site investigator's medical judgment) 6. Patients with cardiogenic shock or cardiac arrest 7. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 8. Patients with severe valvular heart disease requiring open heart surgery 9. Pregnant or lactating women Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria 1. Subject must be at least 19 years of age 2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily 3. Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥3.0 mm Exclusion Criteria 1. Patients unable to provide consent 2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents 3. Patients with angiographic findings of 1) Left main coronary artery disease 2) In-stent restenosis is the cause of target lesion 3) Target lesion in bypass graft 4) True bifurcation lesion that requires upfront 2-stenting 4. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year 5. Patients who may result in protocol non-compliance (site investigator's medical judgment) 6. Patients with cardiogenic shock or cardiac arrest 7. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 8. Patients with severe valvular heart disease requiring open heart surgery 9. Pregnant or lactating women

Treatments Being Tested

PROCEDURE

Drug-eluting stent implantation

IVUS (OPTICROSS, Boston Scientific, USA) will be recommended to select proper size of predilatation balloon (semi- or non-compliant balloon), DCB, or DES. Optimal lesion preparation is defined as satisfying all of the followings: 1) a fully inflated balloon of the correct size for the vessel (balloon with vessel ratio \>0.90); 2) ≤35% residual stenosis; 3) TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; and 4) the absence of a flow-limiting coronary artery dissection.15 After successful lesion preparation, patients will receive either DCB or DES according to randomly allocated groups. In DES group, latest second-generation DES will be used in accordance with standard practice guideline.

PROCEDURE

Drug-coated balloon angioplasty

IVUS (OPTICROSS, Boston Scientific, USA) will be recommended to select proper size of predilatation balloon (semi- or non-compliant balloon), DCB, or DES. Optimal lesion preparation is defined as satisfying all of the followings: 1) a fully inflated balloon of the correct size for the vessel (balloon with vessel ratio \>0.90); 2) ≤35% residual stenosis; 3) TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; and 4) the absence of a flow-limiting coronary artery dissection.15 After successful lesion preparation, patients will receive either DCB or DES according to randomly allocated groups. In DCB group, commercially available DCB (Agent, Boston Scientific, USA) will be used. DCB angioplasty will be recommended as follows to fully optimized procedural results. First, DCB size should be 1:1 ratio with reference vessel size. Second, delivery time of DCB should be within 30 seconds. Third, total inflation time of DCB will be recommended from 30 to 60 seconds.

Locations (9)

Kosin University Gospel Hospital

Busan, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Chonnam National University

Gwangju, South Korea

Jeonbuk National University Hospital

Jeonju, South Korea

Samsung Medical Center

Seoul, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

Yeosu Jeil Hospital

Yeosu, South Korea