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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)

NCT05438121

Coronary Artery Disease Atherosclerotic Plaque De Novo Stenosis

RECRUITING

Comparison of PROVISIONal 1-stent Strategy with DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.

NCT06002932

Coronary Artery Disease Ischemic Heart Disease

RECRUITING NA

Observational Study for Left Main Disease Treatment

NCT01341327

Coronary Artery Disease

RECRUITING

Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion

NCT04619277

Drug-coated Balloon

RECRUITING

Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions

NCT05096442

Coronary Artery Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, multi-center, off-label, randomized controlled, non-inferiority trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drug-eluting stent

In DES group, latest second-generation DES will be used in accordance with standard practice guideline.

Group Type ACTIVE_COMPARATOR

Drug-eluting stent implantation

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Drug-coated balloon angioplasty

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Young Joon Hong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Young Joon Hong, MD, PhD

Role: STUDY_CHAIR

Chonnam National University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.