Myocardial Infarction (MI)DCB-STEMINCT07436429
Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction
An observational study of Myocardial Infarction (MI) and ST-Elevation Myocardial Infarction, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction (MI), ST-Elevation Myocardial Infarction, STEMI
- What is being tested?
- Drug-Coated Balloon
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- 8 Feb 2026to 1 Jul 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients admitted with STEMI
Who may be able to join
- All ST-elevation MI undergoing Primary PCI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Universitatsklinikum AKH wien
Vienna
Riccardo Terzi, MD, +393312127467, riccardo.terzi1@gmail.com
About this study
Official title: 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.
- Conditions
- Myocardial Infarction (MI), ST-Elevation Myocardial Infarction, STEMI, STEMI (STE-ACS), Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
- Being tested
- Drug-Coated Balloon
- Keywords
- Drug-coated balloon, Primary percutaneous coronary intervention, De novo coronary lesion, Limus-coated balloon, Paclitaxel-coated balloon, Net adverse clinical events, Bleeding Academic Research Consortium bleeding, ST-segment elevation myocardial infarction, Drug-Eluting Balloon
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-Coated BalloonDevice
Also called Drug-Eluting Balloon, DCB, DEB
Provisional DCB-based pPCI for a de novo coronary
| Study group | Role | What they receive |
|---|---|---|
| Adult patients admitted with STEMI (symptom onset within 48 hours prior to the procedure) | Not described Receives: Device: Drug-Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical events (NACE)
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
Measured: From January 2014 to April 2026
Secondary outcomes (3)
Individual NACE components
Measured: Jenuary 2014 to April 2026
Any Bleeding
Any bleeding classified according to the Bleeding Academic Research Consortium (BARC) criteria.
Measured: January 2014- April 2026
Target Vessel Failure (TVF)
Composite of cardiovascular death, target vessel myocardial infarction, or target vessel revascularization, according to Academic Research Consortium drug-coated balloon consensus definitions.
Measured: January 2014-April 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start8 Feb 2026
- Primary completionJul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction (MI)Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rayyan Hemetsberger, Medical University of Vienna
- Investigators
- Rayyan Hemetsberger, MD, Principal investigator, Universitatsklinikum AKH wienMohammad Abdelghani, MD, PhD, Principal investigator, Sohar Hospital, Sohar, Oman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436429
- Sponsor's protocol ID
- 1535/2023
- Acronym
- DCB-STEMI
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Coated Balloon-Based Primary PCI in ST-segment Elevation Myocardial Infarction - The DCB-STEMI Multicenter Registry
- ClinicalTrials.gov ID
- NCT07436429
- Acronym / sponsor ID
- DCB-STEMI / 1535/2023
- Conditions
- Myocardial Infarction (MI), ST-Elevation Myocardial Infarction, STEMI, STEMI (STE-ACS), Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
- Keywords
- Drug-coated balloon, Primary percutaneous coronary intervention, De novo coronary lesion, Limus-coated balloon, Paclitaxel-coated balloon, Net adverse clinical events, Bleeding Academic Research Consortium bleeding, ST-segment elevation myocardial infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 8 Feb 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients admitted with STEMI (symptom onset within 48 hours prior to the procedure) | – | Device: Drug-Coated Balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients admitted with STEMI
Key inclusion criteria (1 listed)
- All ST-elevation MI undergoing Primary PCI
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-Coated BalloonAlso: Drug-Eluting Balloon, DCB, DEBProvisional DCB-based pPCI for a de novo coronary | Device | Adult patients admitted with STEMI (symptom onset within 48 hours prior to the procedure) |
Primary outcome
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
3 secondary outcomes
Individual NACE components
Time frame: Jenuary 2014 to April 2026
Any Bleeding
Time frame: January 2014- April 2026
Target Vessel Failure (TVF)
Time frame: January 2014-April 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rayyan Hemetsberger, MD principal investigator
Universitatsklinikum AKH wien
Mohammad Abdelghani, MD, PhD principal investigator
Sohar Hospital, Sohar, Oman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction (MI) and ST-Elevation Myocardial Infarction, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Terzi, MD, BSc (+393312127467, riccardo.terzi1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net adverse clinical events (NACE) (time frame: From January 2014 to April 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.