Coronary Artery DiseasePREVAILNCT07373145
Prospective CT Assessment After DCB
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 165 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2025to 1 Dec 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who took coronary computed tomography angiography (CCTA) and received drug-coated balloon (DCB) treatment for coronary artery disease
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Bon-kwon Koo, MD, PhD, 82-2-2072-2062
Junpil Yun, MD, 82-10-8001-9969, junpilyun@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- drug coated balloon, CCTA, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Changes in ΔFFR CT before and after DCB procedure
Measured: From baseline CCTA to follow-up CCTA performed 2 years after the index PCI
Secondary outcomes (2)
Changes in plaque characteristics before and after DCB procedure
Measured: From baseline CCTA to follow-up CCTA performed 2 years after the index PCI
Changes in diameter stenosis before and after DCB procedure
Measured: From baseline CCTA to follow-up CCTA performed 2 years after the index PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Aug 2025
- Primary completion1 Aug 2031 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ulsan University Hospital, National Health Insurance Service Ilsan Hospital, KangWon National University Hospital, Korea University Guro Hospital, Sejong General Hospital, Hanyang University Seoul Hospital
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373145
- Sponsor's protocol ID
- H-2404-105-1532
- Other IDs
- ERP-2024-13777
- Acronym
- PREVAIL
- Status last verified
- Jan 2026
- First submitted
- 8 Aug 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sharing plan will be decided by the study committee.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Evaluation of Vascular Alterations in CT Angiography After Intervention With Drug-coated Balloon (PREVAIL) Study
- ClinicalTrials.gov ID
- NCT07373145
- Acronym / sponsor ID
- PREVAIL / H-2404-105-1532
- Conditions
- Coronary Artery Disease
- Keywords
- drug coated balloon, CCTA, coronary artery disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ulsan University Hospital, National Health Insurance Service Ilsan Hospital, KangWon National University Hospital, Korea University Guro Hospital, Sejong General Hospital, Hanyang University Seoul Hospital
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2031 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who took coronary computed tomography angiography (CCTA) and received drug-coated balloon (DCB) treatment for coronary artery disease
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided. The sharing plan will be decided by the study committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bon-kwon Koo, MD, PhD (82-2-2072-2062, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.