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Clinical Trials in China / NCT07806370
Recruiting Observational

A Single-Center, Retrospective, Propensity-Score-Matched Cohort Study Comparing Drug-Coated Balloon Versus Drug-Eluting Stent for Reducing Immediate Post-Procedural Slow-Flow/No-Reflow in Acute ST-Elevation Myocardial Infarction Patients With High Thrombus Burden

NCT07806370 · tracked via the Priya Life Science China tracker
Sponsor
Xijing Hospital
Phase
Observational
Started
2019-01-01
Last updated
2026-09-08

Condition(s) studied

ST Elevation Myocardial Infarction (STEMI)Acute Coronary Syndromes (ACS)

Investigational drug(s) / intervention(s)

Drug-Coated Balloon (DCB)Drug-Eluting Stent (DES)

Drug-Coated Balloon (DCB): 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.

Drug-Eluting Stent (DES): 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients diagnosed with ST-elevation myocardial infarction (STEMI) undergoing emergency percutaneous coronary intervention (PCI) at this center: * Symptom onset ≤ 12 hours; OR * Symptom onset \> 12 hours with persistent ischemic symptoms. 2. Angiographic thrombus grade of the culprit vessel is G2-G4. 3. Reference vessel diameter of the culprit vessel: 2.25-4.0 mm. 4. Complete pre-procedural and post-procedural coronary angiographic imaging data are available. 5. Age ≥ 18 years old. Exclusion Criteria: 1. Participation in other clinical trials. 2. Cardiogenic shock or post-cardiac-arrest resuscitation state. 3. Multi-vessel coronary artery disease. 4. Severe calcified lesions requiring rotational atherectomy or shock-wave therapy. 5. Only compliant or non-compliant plain balloon dilation performed. 6. Both DES and DCB applied to the same culprit vessel. 7. Culprit lesion located in a coronary bypass graft, or in-stent restenosis / in-stent thrombosis. 8. Missing key angiographic or clinical follow-up data.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Fourth Military Medical University Xi'an Shaanxi Recruiting

More Xijing Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07806370 on ClinicalTrials.gov ↗ ← All trials in China