Drug-coated balloon treatment during emergency angioplasty for STEMI
Drug Coated Balloon-Based Primary PCI in ST-segment Elevation Myocardial Infarction - The DCB-STEMI Multicenter Registry
This registry will try using drug-coated balloons instead of stents during emergency PCI for people with ST-elevation heart attacks to see how the procedure and patient outcomes compare.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT07436429 on ClinicalTrials.gov |
What this trial studies
This observational registry enrolls patients presenting with ST-elevation myocardial infarction who undergo primary percutaneous coronary intervention using a drug-coated balloon-based strategy. Procedural details, in-hospital events, and follow-up clinical outcomes will be collected to characterize safety and efficacy in the acute STEMI setting. Key exclusions include in-stent culprit lesions, recent stent implantation, contraindications to antiplatelet therapy, cardiac arrest/intubation, cardiogenic shock, or expected life-expectancy under one year. The registry is conducted at the Medical University of Vienna (Universitatsklinikum AKH Wien).
Who should consider this trial
Good fit: Ideal candidates are adults presenting with ST-elevation myocardial infarction who undergo primary PCI, can receive antiplatelet therapy, and do not have a culprit lesion already containing a stent or a recent stent placed within three months.
Not a fit: Patients with in-stent culprit lesions, recent stent implantation within three months, contraindications to antiplatelet drugs, cardiac arrest, intubation, cardiogenic shock, or a life expectancy under one year are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, a drug-coated balloon approach could simplify emergency angioplasty and reduce stent-related complications such as late thrombosis and restenosis.
How similar studies have performed: Small observational series and pilot studies suggest feasibility of drug-coated balloons for de novo coronary lesions, but data specifically for primary PCI in STEMI are limited and randomized evidence is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All ST-elevation MI undergoing Primary PCI Exclusion Criteria: * In-stent culprit lesion * Contraindications to antiplatelets * Stent implantation within 3 months before enrollment * Cardiac arrest, intubation, or cardiogenic shock * Life-expectancy less than one year
Where this trial is running
Vienna
- Universitatsklinikum AKH wien — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Rayyan Hemetsberger, MD — Universitatsklinikum AKH wien
- Study coordinator: Riccardo Terzi, MD, BSc
- Email: riccardo.terzi1@gmail.com
- Phone: +393312127467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.