RecruitingNot Applicable

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

South Korea256 participantsStarted 2025-08-18

Plain-language 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).

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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%)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Late-lumen loss

Timeframe: 9 months after last patient enrollment

Trial details

NCT IDNCT06954714

SponsorChonnam National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Seung Hun Lee, MD, PhD

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

View on ClinicalTrials.gov More Coronary Artery Disease trials