Prospective CT Assessment After DCB

PRospective Evaluation of Vascular Alterations in CT Angiography After Intervention With Drug-coated Balloon (PREVAIL) Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07373145

Acronym

PREVAIL

Enrollment

165

Registered

2026-01-28

Start date

2025-08-01

Completion date

2032-12-01

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

drug coated balloon, CCTA, coronary artery disease

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes in ΔFFR CT before and after DCB procedure	From baseline CCTA to follow-up CCTA performed 2 years after the index PCI

Secondary

Measure	Time frame
Changes in plaque characteristics before and after DCB procedure	From baseline CCTA to follow-up CCTA performed 2 years after the index PCI
Changes in diameter stenosis before and after DCB procedure	From baseline CCTA to follow-up CCTA performed 2 years after the index PCI

Countries

South Korea

Contacts

CONTACTBon-kwon Koo, MD, PhD

bkkoo@snu.ac.kr82-2-2072-2062

CONTACTJunpil Yun, MD

junpilyun@gmail.com82-10-8001-9969

Outcome results