An observational study in ST Elevation Myocardial Infarction (STEMI) and Acute Coronary Syndromes (ACS), sponsored by Xijing Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Xijing Hospital · Observational
This is a single-center, retrospective, propensity-score-matched observational study. It aims to compare the rate of immediate slow-flow or no-reflow after percutaneous coronary intervention (PCI) between drug-coated balloon (DCB) and drug-eluting stent (DES) in STEMI patients with high thrombus burden. Medical records of eligible patients admitted between January 1, 2019 and June 30, 2025 will be reviewed. Propensity-score matching will be used to balance baseline characteristics of the two groups. Both procedural-related outcomes and 1-year clinical follow-up events will be analyzed.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 668 is above the median of 335 across 297 observational studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
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This is a single-center retrospective observational study. The study population consists of patients diagnosed with ST-elevation myocardial infarction (STEMI) with high thrombus burden (angiographic thrombus grade G2-G4) who underwent emergency percutaneous coronary intervention (PCI) at Xijing Hospital between January 1, 2019 and June 30, 2025. Eligible patients received either drug-coated balloon (DCB) or drug-eluting stent (DES) as the final revascularization strategy for the culprit vessel. Patients are identified from in-hospital medical records and coronary angiographic databases.
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Patients diagnosed with ST-elevation myocardial infarction (STEMI) undergoing emergency percutaneous coronary intervention (PCI) at this center:
Exclusion Criteria:
STEMI patients with high thrombus burden who received drug-coated balloon (DCB) as the final revascularization strategy for culprit coronary vessel
Device: Drug-Coated Balloon (DCB)
STEMI patients with high thrombus burden who received drug-eluting stent (DES) implantation as the final revascularization strategy for culprit coronary vessel, including bailout DES implantation after DCB.
Device: Drug-Eluting Stent (DES)
A drug-coated balloon catheter used for percutaneous coronary intervention in patients with STEMI and high thrombus burden. The balloon surface is coated with an antiproliferative drug (e.g., paclitaxel) that is transferred to the vessel wall during balloon inflation, inhibiting neointimal hyperplasia. No permanent metal scaffold is implanted after DCB-only revascularization.
A permanent coronary metal scaffold coated with an antiproliferative drug (e.g., sirolimus, everolimus, zotarolimus, or biolimus) implanted during percutaneous coronary intervention. The stent maintains vessel patency and the eluted drug inhibits neointimal hyperplasia. Used for culprit-vessel revascularization in STEMI patients with high thrombus burden, including bailout DES implantation after DCB predilation.
Incidence of immediate slow-flow or no-reflow after PCI
The incidence of immediate slow-flow or no-reflow phenomenon after percutaneous coronary intervention (PCI) with either drug-coated balloon (DCB) or drug-eluting stent (DES). Slow-flow/no-reflow is defined as TIMI flow grade ≤2 after the procedure in the absence of mechanical obstruction, dissection, or severe spasm.
Time frame: Immediately after the index emergency PCI procedure
Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
Composite endpoint of all-cause death, non-fatal myocardial infarction, stroke, and any revascularization within 1-year after index emergency PCI.
Time frame: 1 year after index emergency PCI procedure
Incidence of Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
The overall incidence of Patient-oriented Composite Endpoint (PoCE) within 1-year after index emergency PCI. PoCE is defined as a composite of all-cause death, non-fatal myocardial infarction, stroke, and any revascularization. This endpoint is assessed through in-hospital medical records, outpatient follow-up records, and telephone follow-up data.
Time frame: 1 year after index emergency PCI procedure
Individual components of PoCE at 1-year follow-up
Incidence of each separate component event of PoCE: all-cause death, non-fatal myocardial infarction, stroke, any revascularization. This endpoint is assessed through in-hospital medical records, outpatient follow-up records, and telephone follow-up data.
Time frame: 1 year after index emergency PCI procedure
Device-oriented Composite Endpoint (DoCE) at 1-year follow-up
Composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-driven target-lesion revascularization (CI-TLR) within 1-year after index emergency PCI.
Time frame: 1 year after index emergency PCI procedure
Individual components of DoCE at 1-year follow-up
Incidence of each separate component event of DoCE: cardiac death, target-vessel myocardial infarction (TV-MI), clinically-driven target-lesion revascularization (CI-TLR).
Time frame: 1 year after index emergency PCI procedure
Target Vessel Failure (TVF) at 1-year follow-up
Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target-vessel revascularization within 1-year after index emergency PCI.
Time frame: 1 year after index emergency PCI procedure
Clinically-driven target-vessel revascularization at 1-year follow-up
Revascularization of target vessel triggered by clinical symptoms or myocardial ischemia evidence within 1-year after index emergency PCI.
Time frame: 1 year after index emergency PCI procedure
Net Adverse Clinical Events (NACE) at 1-year follow-up
Composite of PoCE plus BARC-defined type 3 or 5 bleeding events within 1-year after index emergency PCI.
Time frame: 1 year after index emergency PCI procedure
BARC type 3 or 5 bleeding events at 1-year follow-up
Bleeding events meeting BARC (Bleeding Academic Research Consortium) type 3 or type 5 criteria within 1-year after index emergency PCI.
Time frame: 1 year after index emergency PCI procedure
Plan to share: No — Individual-level patient data will not be shared due to patient privacy protection requirements and local hospital data management regulations. This is a single-center retrospective study based on historical medical records. No formal data sharing mechanism has been established. Aggregated study results may be published in peer-reviewed journals.
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