Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction (DCB-STEMI)

February 22, 2026 updated by: Rayyan Hemetsberger, Medical University of Vienna

Drug Coated Balloon-Based Primary PCI in ST-segment Elevation Myocardial Infarction - The DCB-STEMI Multicenter Registry

Drug-eluting stent (DES)-based primary percutaneous intervention (pPCI) has been established as the standard of care for patients presenting with ST-segment elevation myocardial infarction (STEMI), having demonstrated superiority over thrombolysis, plain balloon angioplasty, and bare-metal stents. Recently, the use of drug-coated balloons (DCB) has expanded dramatically across a variety of anatomical and clinical settings, including de novo coronary lesions. A DCB-based pPCI strategy may simplify the procedure and mitigate the risks of inadequate stent sizing due to spasm or large thrombus burden, acute stent thrombosis, distal embolization, no reflow, and the relatively higher incidence of late stent-related adverse events compared with elective PCI. Despite these theoretical advantages, data on the safety and efficacy of DCB-based pPCI in STEMI remains limited.

The aim of this registry is to explore procedural and clinical outcomes of patients with STEMI treated with a DCB-based pPCI strategy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive adult patients admitted with STEMI

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients admitted with STEMI (symptom onset within 48 hours prior to the procedure)
Device: Drug-Coated Balloon
Provisional DCB-based pPCI for a de novo coronary
Other Names:
  • DEB
  • DCB
  • Drug-Eluting Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net adverse clinical events (NACE)
Time Frame: From January 2014 to April 2026
Composite of :Device success, Procedural success, Angiographic success diameter stenosis <40% by visual estimation and TIMI flow grade ≥2, Target vessel dissection ≥ type C, Bailout stenting
From January 2014 to April 2026

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual NACE components
Time Frame: Jenuary 2014 to April 2026
Jenuary 2014 to April 2026
Any Bleeding
Time Frame: January 2014- April 2026
Any bleeding classified according to the Bleeding Academic Research Consortium (BARC) criteria.
January 2014- April 2026
Target Vessel Failure (TVF)
Time Frame: January 2014-April 2026
Composite of cardiovascular death, target vessel myocardial infarction, or target vessel revascularization, according to Academic Research Consortium drug-coated balloon consensus definitions.
January 2014-April 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Rayyan Hemetsberger, MD, Universitätsklinikum AKH Wien
  • Principal Investigator: Mohammad Abdelghani, MD, PhD, Sohar Hospital, Sohar, Oman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1535/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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