Evaluating drug-coated balloons for new coronary artery lesions
Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion
Ulsan Medical Center · NCT04619277
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 |
|---|---|
| Enrollment | 10000 (estimated) |
| Sex | All |
| Sponsor | Ulsan Medical Center (other) |
| Locations | 1 site (Ulsan) |
| Trial ID | NCT04619277 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with de novo coronary artery disease.
Not a fit: Patients with unstable hemodynamics at presentation or a life expectancy of less than one year may not benefit from this study.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- de novo coronary artery disease Exclusion Criteria: * unstable hemodynamics at presentation * life expectancy \<1 year
Where this trial is running
Ulsan
- Ulsan Medical Center — Ulsan, South Korea (RECRUITING)
Study contacts
- Principal investigator: Soo-Jin Kim — IRB
- Study coordinator: Eun-Seok Shin
- Email: sesim1989@gmail.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Drug-coated Balloon