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.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Ulsan Medical Center Academic / other |
| Locations | 1 site (Ulsan) |
| Status | Recruiting |
| Started | April 22, 2011 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | August 15, 2024 |
| Trial ID | NCT04619277 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
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Impact of Procedural Factors on Drug-Coated Balloon Outcomes in Coronary Artery Disease
This registry tests whether delivery time and inflation duration of drug-coated balloons affect outcomes in adults undergoing PCI for new coronary lesions.
-
Crystalline sirolimus-coated balloon for treating coronary artery disease
This tests whether a crystalline sirolimus-coated balloon is safe and effective for adults having percutaneous coronary intervention for coronary artery blockages or in-stent restenosis.
-
Long Passeo-18 Lux balloon for leg artery blockages
A single-arm trial tests a long paclitaxel-releasing balloon to treat new or recurring leg artery blockages in adults.
-
Outcomes after PCI using the Protégé paclitaxel drug-coated balloon.
This registry will collect real-world data to see if the Protégé paclitaxel drug-coated balloon works well and is safe for adults having PCI for coronary artery disease or acute coronary syndrome.
-
Drug-coated balloon with bail-out bioresorbable scaffold versus scaffold alone for new coronary artery blockages
This test sees if using a drug-coated balloon with bail-out bioresorbable scaffold works as well as using a bioresorbable scaffold alone for adults 18–68 getting PCI for new coronary artery blockages, including certain heart attacks and unstable angina.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.