Coronary Artery DiseaseLARGER-DCBNCT06954714
Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
A study testing Drug-eluting stent implantation and Drug-coated balloon angioplasty in people with Coronary Artery Disease, run by Chonnam National University Hospital at 8 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Drug-eluting stent implantation and Drug-coated balloon angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 18 Aug 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
- Patients with severe valvular heart disease requiring open heart surgery
- Pregnant or lactating women
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
South Korea8 sites, 8 recruiting
- Not yet recruiting
Kosin University Gospel Hospital
Busan, 49269
Jung Ho Heo, MD, PhD, duggymdc@gmail.com
Jung Ho Heo, MD, PhD
- Not yet recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
Hyuck-Jun Yoon, MD, PhD, hippsons@gmail.com
Hyuck-Jun Yoon, MD, PhD
- Recruiting
Chonnam National University
Gwangju, 61469
Young Joon Hong, MD, PhD, hyj200@hanmail.net
Seung Hun Lee, MD, PhD, lsh8602@naver.com
- Not yet recruiting
Jeonbuk National University Hospital
Jeonju, 54907
Yi Sik Kim, MD, PhD
Yi Sik Kim, MD, PhD
- Not yet recruiting
Samsung Medical Center
Seoul, 06351
Joo Myung Lee, MD, PhD, drone80@hanmail.net
Joo Myung Lee, MD, PhD
- Not yet recruiting
Ewha Womans University Mokdong Hospital
Seoul, 07985
Sodam Jung, MD, PhD, cvdosam@gmail.com
Sodam Jung, MD, PhD
- Not yet recruiting
Korea University Guro Hospital
Seoul, 08308
Dong Oh Kang, MD, PhD, gelly9@naver.com
Dong Oh Kang, MD, PhD
- Not yet recruiting
Ulsan University Hospital
Ulsan, 44033
Eun Seok Shin, MD, PhD, sesim1989@gmail.com
Eun Seok Shin, MD, PhD
About this study
This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
Read the 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).
- Conditions
- Coronary Artery Disease
- Being tested
- Drug-eluting stent implantation, Drug-coated balloon angioplasty
- Keywords
- drug-coated balloon, intravascular ultrasound
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting stent implantationProcedure or surgery
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.
Drug-coated balloon angioplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting stent | Active comparator | In DES group, latest second-generation DES will be used in accordance with standard practice guideline. Receives: Procedure: Drug-eluting stent implantation |
| Drug-coated balloon | Experimental | 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. Receives: Procedure: Drug-coated balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late-lumen loss
Mean difference of late-lumen loss between DCB and DES in IVUS
Measured: 9 months after last patient enrollment
Secondary outcomes (19)
Minimal lumen diameter in QCA
Mean difference of minimal lumen diameter in QCA
Measured: 9 months after last patient enrollment
% diameter stenosis in QCA
Mean difference of % diameter stenosis in QCA
Measured: 9 months after last patient enrollment
Minimal lumen diameter in IVUS
Mean difference of minimal lumen diameter in IVUS
Measured: 9 months after last patient enrollment
Cardiovascular death
Cardiovascular death
Measured: 1 year after last patient enrollment
All-cause death
All-cause death
Measured: 1 year after last patient enrollment
Rate of target vessel-MI
Target vessel-MI
Measured: 1 year after last patient enrollment
Rate of non-fatal MI
Non-fatal MI
Measured: 1 year after last patient enrollment
Rate of target lesion revascularization
Clinically indicated target lesion revascularization
Measured: 1 year after last patient enrollment
Rate of target vessel revascularization
Clinically indicated target vessel revascularization
Measured: 1 year after last patient enrollment
Rate of any revascularization
Any revascularization
Measured: 1 year after last patient enrollment
Rate of vessel or stent thrombosis
Definite or probable thrombosis
Measured: 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
Measured: 1 year after last patient enrollment
All-cause death or non-fatal MI
A composite of all-cause death or non-fatal myocardial infarction
Measured: 1 year after last patient enrollment
Target vessel failure
A composite of cardiovascular death, target-vessel myocardial infarction, and clinically indicated target vessel revascularization
Measured: 1 year after last patient enrollment
Target lesion failure
A composite of cardiovascular death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization
Measured: 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
Measured: 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
Measured: 1 year after last patient enrollment
BARC type 2, 3, or 5 bleeding
BARC type 2, 3, or 5 bleeding
Measured: 1 year after last patient enrollment
Cerebrovascular accident
Ischemic stroke, hemorrhagic stroke, or transient ischemic attack
Measured: 1 year after last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start18 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, multi-center, off-label, randomized controlled, non-inferiority trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Young Joon Hong, Chonnam National University Hospital
- Investigators
- Young Joon Hong, MD, PhD, Study chair, Chonnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954714
- Sponsor's protocol ID
- CNUH-2025-115
- Acronym
- LARGER-DCB
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
- ClinicalTrials.gov ID
- NCT06954714
- Acronym / sponsor ID
- LARGER-DCB / CNUH-2025-115
- Conditions
- Coronary Artery Disease
- Keywords
- drug-coated balloon, intravascular ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, multi-center, off-label, randomized controlled, non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting stent | Active comparator | Procedure: Drug-eluting stent implantationIn DES group, latest second-generation DES will be used in accordance with standard practice guideline. |
| Drug-coated balloon | Experimental | Procedure: Drug-coated balloon angioplastyIn 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-eluting stent implantationIVUS (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 or surgery | Drug-eluting stent |
| Drug-coated balloon angioplastyIVUS (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. | Procedure or surgery | Drug-coated balloon |
Primary outcome
Late-lumen loss
Time frame: 9 months after last patient enrollment
Mean difference of late-lumen loss between DCB and DES in IVUS
19 secondary outcomes
Minimal lumen diameter in QCA
Time frame: 9 months after last patient enrollment
% diameter stenosis in QCA
Time frame: 9 months after last patient enrollment
Minimal lumen diameter in IVUS
Time frame: 9 months after last patient enrollment
Cardiovascular death
Time frame: 1 year after last patient enrollment
All-cause death
Time frame: 1 year after last patient enrollment
Rate of target vessel-MI
Time frame: 1 year after last patient enrollment
Rate of non-fatal MI
Time frame: 1 year after last patient enrollment
Rate of target lesion revascularization
Time frame: 1 year after last patient enrollment
Rate of target vessel revascularization
Time frame: 1 year after last patient enrollment
Rate of any revascularization
Time frame: 1 year after last patient enrollment
Rate of vessel or stent thrombosis
Time frame: 1 year after last patient enrollment
Cardiovascular death or target vessel-related myocardial infarction
Time frame: 1 year after last patient enrollment
All-cause death or non-fatal MI
Time frame: 1 year after last patient enrollment
Target vessel failure
Time frame: 1 year after last patient enrollment
Target lesion failure
Time frame: 1 year after last patient enrollment
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
Time frame: 1 year after last patient enrollment
All-cause death, non-fatal myocardial infarction, or target vessel revascularization
Time frame: 1 year after last patient enrollment
BARC type 2, 3, or 5 bleeding
Time frame: 1 year after last patient enrollment
Cerebrovascular accident
Time frame: 1 year after last patient enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. Yes After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Young Joon Hong, MD, PhD study chair
Chonnam National University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting stent implantation and Drug-coated balloon angioplasty in people with Coronary Artery Disease, run by Chonnam National University Hospital at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seung Hun Lee, MD, PhD (+82-62-220-6246, lsh8602@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late-lumen loss (time frame: 9 months after last patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.