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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Drug-eluting stent implantation; Procedure: Drug-coated balloon angioplasty

Detailed Description

Drug-eluting stent (DES) is the standard of care for patients with coronary artery disease who are eligible for percutaneous coronary intervention (PCI).1 During long-term follow-up, remained metallic stent strut continuously related with stent-related cardiovascular events.2 As an alternative option to DES, drug-coated balloon (DCB) which has benefit of having shorter DAPT maintenance duration due to the absence of metallic scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT),3,4 its use has been established in in-stent restenosis of bare-metal stents and DES.5 Furthermore, recent RCTs demonstrated efficacy and safety of DCB in de novo coronary lesions in small vessels with reference vessel size <3.0mm.6,7 For the patients with de novo, non-complex coronary artery lesions, REC-CAGEFREE I tested the non-inferiority of DCB angioplasty with DES implantation, irrespective of vessel diameter.8 Overall, 2272 patients were randomly assigned to the DCB or the DES group. At 2 years, adverse events occurred in 6.4% of DCB group and 3.4% of DES group and failed to prove the non-inferiority of DCB angioplasty (P for non-inferiority=0.65). Regarding the heterogenous results, it is questionable that DCB angioplasty for large de novo lesions is safe and effective compared with DES implantation.

On this background, the current study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seung Hun Lee, MD, PhD; Phone Number: +82-62-220-6246; Email: lsh8602@naver.com
• Study Contact Backup: Name: Joon Ho Ahn, MD, PhD; Phone Number: +82-62-220-5778; Email: yhbky@naver.com

Study Locations

• South Korea
  • Busan
    • Busan, Busan, South Korea, 49269
      • Not yet recruiting
      • Kosin University Gospel Hospital
      • Contact: Jung Ho Heo, MD, PhD; Email: duggymdc@gmail.com
      • Principal Investigator: Jung Ho Heo, MD, PhD
  • Daegu
    • Daegu, Daegu, South Korea, 42601
      • Not yet recruiting
      • Keimyung University Dongsan Hospital
      • Contact: Hyuck-Jun Yoon, MD, PhD; Email: hippsons@gmail.com
      • Principal Investigator: Hyuck-Jun Yoon, MD, PhD
  • Gwangju
    • Gwangju, Gwangju, South Korea, 61469
      • Recruiting
      • Chonnam National University
      • Contact: Seung Hun Lee, MD, PhD; Email: lsh8602@naver.com
      • Sub-Investigator: Seung Hun Lee, MD, PhD
      • Contact: Young Joon Hong, MD, PhD; Email: hyj200@hanmail.net
      • Principal Investigator: Young Joon Hong, MD, PhD
      • Sub-Investigator: Joon Ho Ahn, MD, PhD
  • Jeonju
    • Jeonju, Jeonju, South Korea, 54907
      • Not yet recruiting
      • Jeonbuk National University Hospital
      • Contact: Yi Sik Kim, MD, PhD
      • Principal Investigator: Yi Sik Kim, MD, PhD
  • Seoul
    • Seoul, Seoul, South Korea, 06351
      • Not yet recruiting
      • Samsung Medical Center
      • Contact: Joo Myung Lee, MD, PhD; Email: drone80@hanmail.net
      • Sub-Investigator: Ki Hong Choi, MD, PhD
      • Sub-Investigator: Young Bin Song, MD, PhD
      • Principal Investigator: Joo Myung Lee, MD, PhD
    • Seoul, Seoul, South Korea, 07985
      • Not yet recruiting
      • Ewha Womans University MokDong Hospital
      • Contact: Sodam Jung, MD, PhD; Email: cvdosam@gmail.com
      • Principal Investigator: Sodam Jung, MD, PhD
    • Seoul, Seoul, South Korea, 08308
      • Not yet recruiting
      • Korea University Guro Hospital
      • Contact: Dong Oh Kang, MD, PhD; Email: gelly9@naver.com
      • Principal Investigator: Dong Oh Kang, MD, PhD
  • Ulsan
    • Ulsan, Ulsan, South Korea, 44033
      • Not yet recruiting
      • Ulsan University Hospital
      • Principal Investigator: Eun Seok Shin, MD, PhD
      • Contact: Eun Seok Shin, MD, PhD; Email: sesim1989@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug-eluting stent; In DES group, latest second-generation DES will be used in accordance with standard practice guideline.	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.
Experimental: Drug-coated balloon; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late-lumen loss	Mean difference of late-lumen loss between DCB and DES in IVUS	9 months after last patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	All-cause death	1 year after last patient enrollment
Cardiovascular death	Cardiovascular death	1 year after last patient enrollment
Rate of any revascularization	Any revascularization	1 year after last patient enrollment
Minimal lumen diameter in QCA	Mean difference of minimal lumen diameter in QCA	9 months after last patient enrollment
% diameter stenosis in QCA	Mean difference of % diameter stenosis in QCA	9 months after last patient enrollment
Minimal lumen diameter in IVUS	Mean difference of minimal lumen diameter in IVUS	9 months after last patient enrollment
Rate of target vessel-MI	Target vessel-MI	1 year after last patient enrollment
Rate of non-fatal MI	Non-fatal MI	1 year after last patient enrollment
Rate of target lesion revascularization	Clinically indicated target lesion revascularization	1 year after last patient enrollment
Rate of target vessel revascularization	Clinically indicated target vessel revascularization	1 year after last patient enrollment
Rate of vessel or stent thrombosis	Definite or probable thrombosis	1 year after last patient enrollment
Cardiovascular death or target vessel-related myocardial infarction	A composite of cardiovascular death or target vessel-related myocardial infarction	1 year after last patient enrollment
All-cause death or non-fatal MI	A composite of all-cause death or non-fatal myocardial infarction	1 year after last patient enrollment
Target vessel failure	A composite of cardiovascular death, target-vessel myocardial infarction, and clinically indicated target vessel revascularization	1 year after last patient enrollment
Target lesion failure	A composite of cardiovascular death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization	1 year after last patient enrollment
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis	A composite of cardiovascular death, target-vessel MI, or vessel or stent thrombosis	1 year after last patient enrollment
All-cause death, non-fatal myocardial infarction, or target vessel revascularization	A composite of all-cause death, non-fatal myocardial infarction, or target vessel revascularization	1 year after last patient enrollment
BARC type 2, 3, or 5 bleeding	BARC type 2, 3, or 5 bleeding	1 year after last patient enrollment
Cerebrovascular accident	Ischemic stroke, hemorrhagic stroke, or transient ischemic attack	1 year after last patient enrollment

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Collaborators: Boston Scientific Corporation
• Investigators: Study Chair: Young Joon Hong, MD, PhD, Chonnam National University

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: drug-coated balloon; intravascular ultrasound
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: CNUH-2025-115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.
• IPD Sharing Time Frame: After publication of main paper.
• IPD Sharing Access Criteria: Executive Committee will discuss to share the de-identified data upon reasonable requests.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No