ST Elevation Myocardial Infarction
Conditions
Keywords
STEMI
Brief summary
The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI). Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies: * Study group: reduced stent PCI strategy (DCB-based) * Control group: conventional PCI strategy (DES-based).
Interventions
DEVICEPrimary PCI
Coronary percutaneous revascularization
Sponsors
Jorge Sanz Sanchez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients presenting with STEMI and indication to undergo pPCI.
Exclusion criteria
* Life expectancy \<1 year due 1 to non-cardiac disease. * Inability to provide informed consent. * Cardiogenic shock. * Left ventricular ejection fraction \<15%. * Left main disease. * Stent thrombosis * Patients with prior bypass graft lesions requiring PCI (culprit or non culprit lesions). * Patients with chronic total occlusions. * Untreatable coronary disease. * Non-identified culprit lesion. * Known allergy to aspirin, ticagrelor, prasugrel, clopidogrel, paclitaxel or sirolimus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure (TLF) | 12 months | Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of myocardial infarction | 10 years | Physicians Assessment |
| Incidence of cardiovascular death | 10 years | Physicians Assessment |
| Incidence of target lesion revascularization | 10 years | Physicians Assessment |
| Incidence of stent thrombosis | 10 years | Physicians Assessment |
| Incidence of all-cause death | 10 years | Physicians Assessment |
| Incidence of stroke | 10 years | Physicians Assessment |
| Incidence of acute kidney injury | 10 years | Physicians Assessment |
| Incidence of bleeding | 10 years | Physicians Assessment |
| Incidence of acute vessel closure | 10 years | Physicians Assessment |
Countries
Spain
Contacts
Primary ContactNaiara García Lamas
Backup ContactMarta Fernández Álvarez
Outcome results
None listed