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

NCT06954714 | Recruiting DMC

• 1 other identifier: CNUH-2025-115
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 9

Brief 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).

Conditions

Coronary Artery Disease

Keywords

drug-coated balloon; intravascular ultrasound

Outcome Measures

Primary Outcomes (1)

• Late-lumen loss

  Mean difference of late-lumen loss between DCB and DES in IVUS

  9 months after last patient enrollment

Secondary Outcomes (19)

• Minimal lumen diameter in QCA

  9 months after last patient enrollment

• % diameter stenosis in QCA

  9 months after last patient enrollment

• Minimal lumen diameter in IVUS

  9 months after last patient enrollment

• Cardiovascular death

  1 year after last patient enrollment

• All-cause death

  1 year after last patient enrollment

Study Arms (2)

Drug-eluting stent

ACTIVE COMPARATOR

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

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.

Procedure: Drug-coated balloon angioplasty

Interventions

Drug-eluting stent implantation 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-eluting stent

Drug-coated balloon angioplasty 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.

Drug-coated balloon

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Boston Scientific Corporation: collaborator

Study Sites (9)

Kosin University Gospel Hospital

Busan, 49269, South Korea

NOT YET RECRUITING

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

NOT YET RECRUITING

Chonnam National University

Gwangju, 61469, South Korea

RECRUITING

Jeonbuk National University Hospital

Jeonju, 54907, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

NOT YET RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

NOT YET RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

NOT YET RECRUITING

Ulsan University Hospital

Ulsan, 44033, South Korea

NOT YET RECRUITING

Yeosu Jeil Hospital

Yeosu, 59677, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Young Joon Hong, MD, PhD

  Chonnam National University

  STUDY CHAIR

Central Study Contacts

Seung Hun Lee, MD, PhD

CONTACT

+82-62-220-6246; lsh8602@naver.com

Joon Ho Ahn, MD, PhD

CONTACT

+82-62-220-5778; yhbky@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of main paper.
• Access Criteria: Executive Committee will discuss to share the de-identified data upon reasonable requests.

Locations

KR (9)