NCT07373145Recruiting
Prospective CT Assessment After DCB
PRospective Evaluation of Vascular Alterations in CT Angiography After Intervention With Drug-coated Balloon (PREVAIL) Study
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
This prospective, multicenter observational cohort study aims to investigate changes in target lesion hemodynamic parameters, diameter stenosis, plaque characteristics of CCTA before and after the DCB procedure and evaluate their association with clinical outcomes.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 165 (estimated)
- First submitted
- 8 Aug 2025
- Start date
- Aug 2025
- Primary completion date
- Aug 2031
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07373145
What you commit to
- Study type: Observational
- Planned participants: 165
- From Aug 2025 to the primary completion date, Aug 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a stent previously implanted in the same vessel
- Lesions involving chronic total occlusion or prior coronary artery bypass grafting (CABG).
Lab values
- Patients with eGFR (estimated glomerular filtration rate) \< 45 ml/min/1.73mm2
- Patients with coronary artery calcium score ≥ 1000 as determined by CCTA
Other
- The target lesion is an in-stent restenosis lesion
- Patient requiring emergency salvage stenting in target lesion
- Patients with an expected survival of less than 5 years
- Pregnant or breastfeeding patients
- Patients deemed inappropriate to participate in this study based on the judgment of study investigators
Who the study is looking for
- Patients with Age ≥ 19
- Patients who took CCTA and were found to have coronary artery disease requiring reperfusion
- Patients who underwent DCB within 3 months after CCTA and whose clinical presentation remained largely unchanged from the time of CCTA.
- The target lesion is a de novo lesion with a vessel diameter between 2.25mm and 3.00mm
- Patients deemed suitable for coronary intervention using drug-coated balloon by clinical assessment
- Patients who have been adequately informed about this study and have voluntarily provided written consent to participate.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.