Actively Recruiting

Age: 18Years +
All Genders
ID07436429

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of ST-elevation myocardial infarction undergoing primary PCI
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Procedure day

Participants undergo provisional drug-coated balloon-based primary percutaneous coronary intervention (PCI) for de novo coronary lesions.

1 visit (in-person)

Long-term Monitoring

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

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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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