Prospective CT Assessment After DCB (PREVAIL)

January 22, 2026 updated by: Bon-Kwon Koo, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bon-kwon Koo, MD, PhD
  • Phone Number: 82-2-2072-2062
  • Email: bkkoo@snu.ac.kr

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Contact:
          • Bon-kwon Koo, MD, PhD
          • Phone Number: 82-2-2072-2062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who took coronary computed tomography angiography (CCTA) and received drug-coated balloon (DCB) treatment for coronary artery disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients treated with a drug-coated balloon for de novo lesions.
Patients who underwent DCB within 3 months after CCTA and whose clinical presentation remained largely unchanged from the time of CCTA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From baseline CCTA to follow-up CCTA performed 2 years after the index PCI

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
From baseline CCTA to follow-up CCTA performed 2 years after the index PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

August 8, 2025

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2404-105-1532
  • ERP-2024-13777 (Other Grant/Funding Number: Medtronic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The sharing plan will be decided by the study committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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