Clinical trial Recruiting at 1 site Observational

Evaluating drug-coated balloons for new coronary artery lesions

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

Run by Ulsan Medical Center · NCT04619277 · Data updated 2026-11-12

This study is testing whether drug-coated balloons can safely and effectively treat new coronary artery blockages better than traditional methods like regular balloon angioplasty and drug-eluting stents.

More Drug Coated Balloon trials

Quick facts

Study typeObservational
SexAll
Enrollment10000 (estimated)
SponsorUlsan Medical Center
Academic / other
Locations1 site (Ulsan)
StatusRecruiting
StartedApril 22, 2011
Main results expectedDecember 31, 2030
Study endsDecember 31, 2030
Registry record updatedAugust 15, 2024
Trial IDNCT04619277 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals diagnosed with de novo coronary artery disease.

Probably not a fit

Patients with unstable hemodynamics at presentation or a life expectancy of less than one year may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international multicenter registry focuses on the use of drug-coated balloons (DCBs) for treating de novo coronary lesions. The study aims to assess the safety and efficacy of DCBs compared to traditional methods like plain old balloon angioplasty and drug-eluting stents. By analyzing clinical and angiographic outcomes, the research seeks to provide insights into the long-term benefits of DCBs in this patient population. The study is particularly relevant given the limited data on DCB-only approaches for new coronary lesions.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with de novo coronary artery disease, potentially reducing complications and enhancing long-term outcomes.

How similar studies have gone: While studies on DCBs for in-stent restenosis have shown success, the application of DCBs for de novo lesions is less explored, making this approach relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

\- de novo coronary artery disease

Exclusion Criteria:

* unstable hemodynamics at presentation
* life expectancy \<1 year

Where it's running

  • Ulsan Medical Center
    Ulsan, South Korea
    Recruiting

Study contacts

  • Principal investigator: Soo-Jin Kim — IRB
  • Study coordinator: Eun-Seok Shin
  • Email: sesim1989@gmail.com

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.