Prospective CT Assessment After DCB
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PRospective Evaluation of Vascular Alterations in CT Angiography After Intervention With Drug-coated Balloon (PREVAIL) Study
Overview
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.
Detailed description
This prospective, multicenter observational cohort study will include patients with coronary artery disease who underwent drug-coated balloon (DCB) treatment and had coronary computed tomography angiography (CCTA) performed at baseline. Follow-up CCTA will be conducted two years after the index DCB procedure. The study aims to evaluate changes in target lesion hemodynamic parameters, diameter stenosis, and plaque characteristics on CCTA before and after DCB treatment, and to assess their association with subsequent clinical outcomes.
Primary outcome measures
- Changes in ΔFFR CT before and after DCB procedure [Time frame: From baseline CCTA to follow-up CCTA performed 2 years after the index PCI]
Secondary outcome measures (2)
- Changes in plaque characteristics before and after DCB procedure [Time frame: From baseline CCTA to follow-up CCTA performed 2 years after the index PCI]
- Changes in diameter stenosis before and after DCB procedure [Time frame: From baseline CCTA to follow-up CCTA performed 2 years after the index PCI]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- The target lesion is an in-stent restenosis lesion
- Patient requiring emergency salvage stenting in target lesion
- Patients with a stent previously implanted in the same vessel
- Lesions involving chronic total occlusion or prior coronary artery bypass grafting (CABG).
- Patients with eGFR (estimated glomerular filtration rate) < 45 ml/min/1.73mm2
- Patients with coronary artery calcium score ≥ 1000 as determined by CCTA
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT07373145 · H-2404-105-1532 · ERP-2024-13777