Clinical trial Recruiting at 1 site Observational Ages 18 to 75

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.

More Acute Coronary Syndromes (ACS) trials

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment668 (estimated)
SponsorXijing Hospital
Academic / other
Locations1 site (Xi'an, Shaanxi)
StatusRecruiting
StartedJanuary 1, 2019
Main results expectedJune 30, 2027
Study endsJanuary 31, 2028
Registry record updatedSeptember 8, 2026
Trial IDNCT07806370 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.