CT scan comparison before and two years after drug-coated balloon treatment for coronary artery disease

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

This study will see if CT scans taken before and two years after drug-coated balloon treatment show changes in artery narrowing, blood flow-related measures, and plaque in people with coronary artery disease.

Quick facts

• Study type: Observational
• Enrollment: 165 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT07373145 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter observational cohort follows patients with coronary artery disease who had baseline coronary CT angiography (CCTA) and underwent drug-coated balloon (DCB) treatment. Enrolled patients will receive follow-up CCTA two years after the index DCB procedure. The study will compare target lesion hemodynamic parameters, diameter stenosis, and plaque characteristics on CCTA before and after DCB. Those imaging changes will be analyzed for associations with subsequent clinical outcomes.

Who should consider this trial

Good fit: Adults (age ≥19) with coronary artery disease who had baseline CCTA and underwent DCB for a de novo target lesion with vessel diameter 2.25–3.00 mm within three months of the CCTA are ideal candidates.

Not a fit: Patients with in-stent restenosis, a stent previously in the same vessel, chronic total occlusion, prior CABG, need for emergency salvage stenting, or significantly reduced kidney function (eGFR <45 ml/min/1.73 m2) are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could help clinicians use noninvasive CT imaging to monitor vessel changes after DCB and better predict patient outcomes.

How similar studies have performed: Prior work has shown DCB can be effective for small-vessel coronary lesions and invasive imaging has documented vessel and plaque changes, but few multicenter studies have used serial CCTA over two years to link imaging changes with outcomes.

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

Where this trial is running

Seoul

• Seoul National University Hospital — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Bon-kwon Koo, MD, PhD

Conditions: Coronary Artery Disease, drug coated balloon, CCTA, coronary artery disease