An observational study in Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), sponsored by Samsung Medical Center. Not yet recruiting at 1 site in South Korea. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Samsung Medical Center · Observational
Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in which long-term maintenance of dual antiplatelet therapy (DAPT) is a clinical dilemma. This target trial emulation aims to compare clinical outcomes between DCB angioplasty and conventional DES implantation in de-novo coronary lesions in patients with coronary artery disease.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 470,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with de novo coronary artery disease for relatively simple lesions undergoing percutaneous coronary intervention
Exclusion Criteria:
Patients receiving drug coated balloon angioplasty
Device: Drug coated balloon
Patients receiving drug-eluting stent implantation
Device: Drug-eluting stent
Patients receiving drug coated balloon angioplasty for de novo coronary artery disease
Patients receiving drug-eluting stent implantationfor de novo coronary artery disease
Rates of MACCE (major adverse cardiac and cerebrovascular events)
all-cause death, myocardial infarction, revascularization, and stroke
Time frame: 3 years after index procedure
Rates of Major bleeding
major bleeding requiring transfusion
Time frame: 3 years after index procedure
Rates of NACE (net adverse clinical events)
MACCE and any major bleeding requiring transfusion
Time frame: 3 years after index procedure
Rates of all-cause death
death from any causes
Time frame: 3 years after index procedure
Rates of myocardial infarction
Time frame: 3 years after index procedure
Rates of revascularization
repeat revascularization
Time frame: 3 years after index procedure
Rates of stroke
Time frame: 3 years after index procedure
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center