Actively Recruiting
Drug Coated Balloon-Based Primary PCI in ST-segment Elevation Myocardial Infarction - The DCB-STEMI Multicenter Registry
Led by Medical University of Vienna · Updated on 2026-02-27
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of drug-coated balloons (DCB) as a primary treatment for patients experiencing ST-segment elevation myocardial infarction (STEMI). This approach is being compared to the current standard care using drug-eluting stents (DES) in primary percutaneous coronary intervention (pPCI). The study aims to explore the safety and effectiveness of DCB-based pPCI, given its potential to reduce complications such as stent thrombosis and late adverse events, which remain concerns with traditional stenting methods. The study observes patients treated with a provisional DCB-based pPCI strategy for new coronary artery blockages. This involves using the drug-coated balloon device during the procedure without immediate stent placement, potentially simplifying the intervention and reducing risks associated with stent use. The registry collects data from patients admitted within 48 hours of symptom onset to evaluate this treatment in real-world settings. Participants are monitored for clinical outcomes including net adverse clinical events (NACE), bleeding events, and target vessel failure from January 2014 through April 2026. The study gathers procedural details and patient follow-up information over this period to assess safety and treatment success. The total participation duration varies, with data collection continuing until mid-2026 to capture both immediate and longer-term outcomes.
CONDITIONS
Brief Title
Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of ST-elevation myocardial infarction undergoing primary PCI
You will not qualify if you...
- In-stent culprit lesion
- Contraindications to antiplatelet medications
- Stent implantation within 3 months before enrollment
- Cardiac arrest, intubation, or cardiogenic shock
- Life expectancy less than one year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo provisional drug-coated balloon-based primary percutaneous coronary intervention (PCI) for de novo coronary lesions.
1 visit (in-person)
Duration - Up to 12 years
Participants are monitored for clinical outcomes including adverse events and target vessel failure.
Follow-up visits according to standard care
Trial Site Locations
Total: 1 location
1
Universitatsklinikum AKH wien
Vienna, Austria
Actively Recruiting
Research Team
R
Riccardo Terzi, MD, BSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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