Comparing reduced stent strategy with conventional stent treatment for heart attack patients
Official title: Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)
Run by Hospital Universitario La Fe · NCT06353594 · Data updated 2026-11-12
This study tests whether using drug-coated balloons instead of regular stents can help heart attack patients recover better after treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1272 (estimated) |
| Sponsor | Hospital Universitario La Fe Academic / other |
| Locations | 23 sites (Huelva, Huelva and 22 other locations) |
| Status | Recruiting |
| Started | March 11, 2024 |
| Main results expected | September 2026 |
| Study ends | September 2035 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT06353594 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients presenting with STEMI who require percutaneous coronary intervention.
✕Probably not a fit
Patients with severe comorbidities, such as life expectancy less than one year or significant heart failure, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of a reduced stent strategy using drug-coated balloons (DCB) compared to the conventional approach of using drug-eluting stents (DES) in patients experiencing ST-segment myocardial infarction (STEMI). Patients will be randomly assigned to either the DCB-based strategy or the DES-based strategy after successful guidewire crossing and restoration of blood flow. The study seeks to determine which method provides better outcomes for patients undergoing percutaneous coronary intervention (PCI).
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for heart attack patients, potentially reducing complications associated with stent placement.
How similar studies have gone: Other studies have explored similar approaches in coronary interventions, but the specific reduced stent strategy using DCB in STEMI patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Hospital Universitario Juan Ramón Jiménez
Huelva, Huelva, Spain Recruiting -
Hospital Universitario Y Politecnico La Fe
Valencia, Valencia, Spain Recruiting -
Complejo Hospitalario Universitario de A Coruña
A Coruña, Spain Recruiting -
Hospital Universitario de Burgos
Burgos, Spain Recruiting -
Consorcio Hospitalario Provincial de Castellon
Castelló, Spain Recruiting -
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Spain Recruiting
Show 17 more locations
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Hospital General Universitario de Elche
Elche, Spain Recruiting -
Hospital Universitario Clínico San Cecilio
Granada, Spain Recruiting -
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain Recruiting -
Hospital Universitario de La Princesa
Madrid, Spain Recruiting -
Hospital Universitario La Paz
Madrid, Spain Recruiting -
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain Recruiting -
Hospital Universitario Regional de Malaga
Málaga, Spain Recruiting -
Hospital de Mérida
Mérida, Spain Recruiting -
Hospital Universitario de Navarra
Pamplona, Spain Recruiting -
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Spain Recruiting -
Hospital Universitario Virgen Del Rocio
Seville, Spain Recruiting -
Hospital Universitari Joan Xxiii de Tarragona
Tarragona, Spain Recruiting -
Hospital Universitario Mutua de Terrassa
Terrassa, Spain Recruiting -
Consorcio Hospital General Universitario de Valencia
Valencia, Spain Recruiting -
Hospital Clinico Universitario de Valladolid
Valladolid, Spain Recruiting -
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain Recruiting -
Hospital Universitario Miguel Servet
Zaragoza, Spain Recruiting
Study contacts
- Principal investigator: Jorge Sanz Sánchez, PI — Hospital Universitario La Fe
- Study coordinator: Naiara García Lamas
- Email: naiara@pinvestiga.com
- Phone: 634213101
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Smartphone AI help for prehospital ECG readings
This study tests whether using a smartphone AI (GPT-4o) to help prehospital providers read 12-lead ECGs improves accuracy in diagnosing acute coronary syndromes and related conditions.
-
Coronary thrombus modification to reduce microvascular damage during STEMI care
This study tests whether modifying the clot in the heart arteries during primary PCI can lessen microvascular damage and myocardial injury in STEMI patients.
-
Crystalline sirolimus-coated balloon for treating coronary artery disease
This tests whether a crystalline sirolimus-coated balloon is safe and effective for adults having percutaneous coronary intervention for coronary artery blockages or in-stent restenosis.
-
Drug-coated balloon treatment during emergency angioplasty for STEMI
This registry will try using drug-coated balloons instead of stents during emergency PCI for people with ST-elevation heart attacks to see how the procedure and patient outcomes compare.
-
Low-level tragus stimulation to improve heart function after ST-elevation heart attack
This trial will see if low-level tragus stimulation applied near the ear can improve heart pumping and wall motion on echocardiogram in people with ST-elevation heart attacks treated with primary PCI.
-
Measuring heart microvascular function in heart attack patients
This study is testing how well the tiny blood vessels in the heart work in people who have had a heart attack to see how treatment affects their recovery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.