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| Name | Class |
|---|---|
| ERA4Health | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB-based | Experimental | Reduced stent PCI strategy: Culprit lesion revascularization with DCB will be performed after coronary predilation if residual stenosis ≤30%, lack of dissections >type B and TIMI 3 flow. If the aforementioned culprit-lesion characteristics are not achieved after DCB-PCI, a DES will be implanted. |
|
| DES-based | No Intervention | Control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary PCI | Device | Coronary percutaneous revascularization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure (TLF) | Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all-cause death | Physicians Assessment | 10 years |
| Incidence of myocardial infarction | Physicians Assessment | 10 years |
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Inclusion Criteria:
- Patients presenting with STEMI and indication to undergo pPCI.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naiara García Lamas | Contact | 634213101 | naiara@pinvestiga.com | |
| Marta Fernández Álvarez | Contact | 604037828 | marta@pinvestiga.com |
| Name | Affiliation | Role |
|---|---|---|
| Jorge Sanz Sánchez, PI | Hospital Universitario La Fe | Principal Investigator |
| Ignacio J Amat Santos, PI | Hospital Universitario de Valladolid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Juan Ramón Jiménez | Recruiting | Huelva | Huelva | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40412715 | Derived | Sanz-Sanchez J, Santos Martinez S, Rumiz Gonzalez E, Oteo Dominguez JF, Tejada Ponce D, Gomez Menchero A, Sanchez Elvira G, Fuertes Ferre G, Rivero Crespo F, Lukic Otanovic A, Diaz Fernandez J, Galindo Fernandez E, Urbano Carrillo C, Salvatella Giralt N, Torres Sanchez M, Garcia Touchard A, Ibanez Cabeza B, Stefanini G, Alfonso Manterola F, Garcia Garcia H, Amat-Santos IJ. Reduced stent strategy versus conventional percutaneous coronary revascularization in patients presenting with STEMI: design of the COPERNICAN trial. Rev Esp Cardiol (Engl Ed). 2026 Feb;79(2):100-105. doi: 10.1016/j.rec.2025.05.005. Epub 2025 May 22. English, Spanish. |
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| Incidence of cardiovascular death | Physicians Assessment | 10 years |
| Incidence of target lesion revascularization | Physicians Assessment | 10 years |
| Incidence of stent thrombosis | Physicians Assessment | 10 years |
| Incidence of acute vessel closure | Physicians Assessment | 10 years |
| Incidence of stroke | Physicians Assessment | 10 years |
| Incidence of acute kidney injury | Physicians Assessment | 10 years |
| Incidence of bleeding | Physicians Assessment | 10 years |
| Hospital Universitario Y Politecnico La Fe | Recruiting | Valencia | Valencia | Spain |
|
| Complejo Hospitalario Universitario de A Coruña | Recruiting | A Coruña | Spain |
|
| Hospital Universitario de Burgos | Recruiting | Burgos | Spain |
|
| Consorcio Hospitalario Provincial de Castellon | Recruiting | Castelló | Spain |
|
| Hospital Universitario Reina Sofía de Córdoba | Recruiting | Córdoba | Spain |
|
| Hospital General Universitario de Elche | Recruiting | Elche | Spain |
|
| Hospital Universitario Clínico San Cecilio | Recruiting | Granada | Spain |
| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Spain |
|
| Hospital Universitario de La Princesa | Recruiting | Madrid | Spain |
|
| Hospital Universitario La Paz | Recruiting | Madrid | Spain |
|
| Hospital Universitario Puerta de Hierro Majadahonda | Recruiting | Madrid | Spain |
|
| Hospital Universitario Regional de Malaga | Recruiting | Málaga | Spain |
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| Hospital de Mérida | Recruiting | Mérida | Spain |
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| Hospital Universitario de Navarra | Recruiting | Pamplona | Spain |
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| Complejo Hospitalario Universitario de Santiago de Compostela | Recruiting | Santiago de Compostela | Spain |
|
| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | Spain |
|
| Hospital Universitari Joan Xxiii de Tarragona | Recruiting | Tarragona | Spain |
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| Hospital Universitario Mutua de Terrassa | Recruiting | Terrassa | Spain |
|
| Consorcio Hospital General Universitario de Valencia | Recruiting | Valencia | Spain |
|
| Hospital Clinico Universitario de Valladolid | Recruiting | Valladolid | Spain |
|
| Hospital Clinico Universitario Lozano Blesa | Recruiting | Zaragoza | Spain |
|
| Hospital Universitario Miguel Servet | Recruiting | Zaragoza | Spain |
|
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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