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NCT Number: NCT07373145

Prospective CT Assessment After DCB

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bon-kwon Koo, MD, PhD

CONTACT

[email protected]

82-2-2072-2062

Junpil Yun, MD

CONTACT

[email protected]

82-10-8001-9969

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Hanyang University Seoul Hospital
  • KangWon National University Hospital
  • Korea University Guro Hospital
  • National Health Insurance Service Ilsan Hospital
  • Sejong General Hospital
  • Ulsan University Hospital

Registry information

Official study title

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

Acronym: PREVAIL

Important dates

Study start
2025
Primary completion
2031
Study completion
2032
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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