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RECRUITING
NCT06954714
NA

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

Sponsor: Chonnam National University Hospital

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2025-08-18

Completion Date

2028-12-31

Last Updated

2025-09-03

Healthy Volunteers

No

Interventions

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