Comparing reduced stent strategy with conventional stent treatment for heart attack patients
Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)
NA · Hospital Universitario La Fe · NCT06353594
This study tests whether using drug-coated balloons instead of regular stents can help heart attack patients recover better after treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1272 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario La Fe (other) |
| Locations | 15 sites (Valencia, Valencia and 14 other locations) |
| Trial ID | NCT06353594 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates for this study are patients presenting with STEMI who require percutaneous coronary intervention.
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.
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 performed: Other studies have explored similar approaches in coronary interventions, but the specific reduced stent strategy using DCB in STEMI patients is relatively novel.
Eligibility criteria
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 this trial is running
Valencia, Valencia and 14 other locations
- Hospital Universitario Y Politecnico La Fe — Valencia, Valencia, Spain (RECRUITING)
- Consorcio Hospitalario Provincial de Castellon — Castelló, Spain (NOT_YET_RECRUITING)
- Hospital General Universitario de Elche — Elche, Spain (NOT_YET_RECRUITING)
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Spain (NOT_YET_RECRUITING)
- Hospital Universitario 12 de Octubre — Madrid, Spain (NOT_YET_RECRUITING)
- Hospital Universitario de La Princesa — Madrid, Spain (NOT_YET_RECRUITING)
- Hospital Universitario Puerta de Hierro Majadahonda — Madrid, Spain (NOT_YET_RECRUITING)
- Hospital Universitario Regional de Malaga — Málaga, Spain (NOT_YET_RECRUITING)
- Hospital Universitario de Navarra — Pamplona, Spain (NOT_YET_RECRUITING)
- Hospital Universitario Virgen Del Rocio — Seville, Spain (NOT_YET_RECRUITING)
- Hospital Universitari Joan Xxiii de Tarragona — Tarragona, Spain (NOT_YET_RECRUITING)
- Consorcio Hospital General Universitario de Valencia — Valencia, Spain (RECRUITING)
- Hospital Clinico Universitario de Valladolid — Valladolid, Spain (NOT_YET_RECRUITING)
- Hospital Clinico Universitario Lozano Blesa — Zaragoza, Spain (NOT_YET_RECRUITING)
- Hospital Universitario Miguel Servet — Zaragoza, Spain (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Jorge Sanz Sánchez, PI — Hospital Universitario La Fe
- Study coordinator: Naiara García Lamas
- Email: naiara@pinvestiga.com
- Phone: 634213101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ST Elevation Myocardial Infarction, STEMI