RecruitingNot ApplicableNCT06954714

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

Sponsor

Chonnam National University Hospital

Enrollment

256 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease

Summary

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

Eligibility

Min Age: 19 Years

Inclusion Criteria3

Subject must be at least 19 years of age
Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily
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 Criteria9

Patients unable to provide consent
Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
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
Patients who have non-cardiac co-morbid conditions with life expectancy <1 year
Patients who may result in protocol non-compliance (site investigator's medical judgment)
Patients with cardiogenic shock or cardiac arrest
Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
Patients with severe valvular heart disease requiring open heart surgery
Pregnant or lactating women

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Interventions

PROCEDUREDrug-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.

PROCEDUREDrug-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.