Drug-coated balloons vs drug-eluting stents for immediate slow-flow/no-reflow in STEMI with high thrombus
Official title: Comparison Of Drug-Coated Balloon Versus Drug-Eluting Stent In STEMI Patients With High Thrombus Burden: A Single-Center Retrospective Study Using Propensity Score Matching
Run by Xijing Hospital · NCT07806370 · Data updated 2026-11-12
This study tests whether using a drug-coated balloon instead of a drug-eluting stent during PCI helps reduce immediate slow-flow or no-reflow in STEMI patients with high thrombus burden.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 668 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | June 30, 2027 |
| Study ends | January 31, 2028 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT07806370 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with STEMI undergoing emergency PCI, with angiographic high thrombus grade (G2-G4) and culprit vessel diameter 2.25–4.0 mm, and complete imaging data.
✕Probably not a fit
Patients with cardiogenic shock, multi-vessel disease, complex lesions requiring advanced techniques, or those receiving both devices on the same culprit vessel may not benefit from the approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, retrospective observational study using propensity-score matching to compare two PCI strategies (DCB vs DES) in STEMI patients with high thrombus burden. Researchers will review medical records from 2019 to 2025, balance baseline characteristics with propensity scores, and analyze procedural outcomes as well as 1-year follow-up events. The study focuses on immediate flow outcomes after intervention and longer-term clinical results. Eligible patients must have STEMI, high thrombus burden, appropriate vessel size, and complete angiographic data. Excluded are patients in other trials, those with cardiogenic shock or multi-vessel disease, and cases where both devices were used on the same culprit vessel.
Why it matters
Potential benefit: If successful, findings could guide PCI device choice to reduce immediate flow problems and potentially improve short- and intermediate-term outcomes in high-thrombus STEMI patients.
How similar studies have gone: Previous observational work has explored DCB versus DES in acute settings, but randomized evidence in this exact high-thrombus STEMI context is limited, making this trial relatively novel but with precedent in related analyses.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
First Affiliated Hospital of Fourth Military Medical University
Xi'an, Shaanxi, China Recruiting
Study contacts
- Study coordinator: Yuan He, MD, PhD
- Email: heyuan820927@163.com
- Phone: +86-13991854483
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Reducing slow-flow and no-reflow during STEMI with a high-dose intracoronary adenosine protocol
In STEMI patients undergoing primary PCI, this trial tests whether giving a high-dose intracoronary adenosine before balloon or stent inflation can prevent slow-flow or no-reflow.
-
Risk of malignant arrhythmias after acute coronary syndrome
This study tracks how often dangerous heart rhythms occur in adults admitted for ACS and looks for patterns that might predict them.
-
New prodrug CG-0255 Besylate vs Plavix in healthy adults
This study tests whether CG-0255 Besylate works similarly to Plavix® in healthy adults to understand how the two drugs behave in the body.
-
CHIP in STEMI: Does clonal hematopoiesis influence infarct severity
This study tests whether clonal hematopoiesis (CHIP) affects infarct size and microvascular injury in people having a heart attack treated with PCI.
-
Biomarker patterns in ACS patients with pneumonia and COPD after flu vaccination
This study tests whether certain blood biomarkers change in people with acute coronary syndrome who also have pneumonia and COPD, and whether flu vaccination affects those biomarker levels.
-
Prehospital High-Sensitivity Troponin I to rule out heart attack for EMS patients
EMS patients with chest pain or possible heart symptoms are being studied to see if a portable hs-TnI test in the ambulance can help identify those at low risk for a heart attack.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.