NCT07436429

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2026Jul 2026

Study Start

First participant enrolled

February 8, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 22, 2026

Last Update Submit

February 22, 2026

Conditions

Myocardial Infarction (MI)ST-Elevation Myocardial InfarctionSTEMISTEMI (STE-ACS)Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

Keywords

Drug-coated balloonPrimary percutaneous coronary interventionDe novo coronary lesionLimus-coated balloonPaclitaxel-coated balloonNet adverse clinical eventsBleeding Academic Research Consortium bleedingST-segment elevation myocardial infarctionDrug-Eluting Balloon

Outcome Measures

Primary Outcomes (1)

  • 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

    From January 2014 to April 2026

Secondary Outcomes (3)

  • Individual NACE components

    Jenuary 2014 to April 2026

  • Any Bleeding

    January 2014- April 2026

  • Target Vessel Failure (TVF)

    January 2014-April 2026

Study Arms (1)

Adult patients admitted with STEMI (symptom onset within 48 hours prior to the procedure)

Device: Drug-Coated Balloon

Interventions

Drug-Coated BalloonDEVICE

Provisional DCB-based pPCI for a de novo coronary

Also known as: Drug-Eluting Balloon, DCB, DEB
Adult patients admitted with STEMI (symptom onset within 48 hours prior to the procedure)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adult patients admitted with STEMI

You may qualify if:

  • All ST-elevation MI undergoing Primary PCI

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitatsklinikum AKH wien

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial InfarctionAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Rayyan Hemetsberger, MD

    Universitatsklinikum AKH wien

    PRINCIPAL INVESTIGATOR

  • Mohammad Abdelghani, MD, PhD

    Sohar Hospital, Sohar, Oman

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo Terzi, MD, BSc

CONTACT

+393312127467riccardo.terzi1@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ap. Prof. Priv.-Doz.

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

February 8, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

AU(1)