Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \- Patients presenting with STEMI and indication to undergo pPCI.
Locations
Other Locations
Spain
Consorcio Hospitalario Provincial de Castellon
NOT_YET_RECRUITING
Castelló
Hospital General Universitario de Elche
NOT_YET_RECRUITING
Elche
Hospital Universitari de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario de La Princesa
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
NOT_YET_RECRUITING
Madrid
Hospital Universitario Regional de Malaga
NOT_YET_RECRUITING
Málaga
Hospital Universitario de Navarra
NOT_YET_RECRUITING
Pamplona
Hospital Universitario Virgen Del Rocio
NOT_YET_RECRUITING
Seville
Hospital Universitari Joan Xxiii de Tarragona
NOT_YET_RECRUITING
Tarragona
Consorcio Hospital General Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario Y Politecnico La Fe
RECRUITING
Valencia
Hospital Clinico Universitario de Valladolid
NOT_YET_RECRUITING
Valladolid
Hospital Clinico Universitario Lozano Blesa
NOT_YET_RECRUITING
Zaragoza
Hospital Universitario Miguel Servet
NOT_YET_RECRUITING
Zaragoza
Contact Information
Primary
Naiara García Lamas
naiara@pinvestiga.com
634213101
Backup
Marta Fernández Álvarez
marta@pinvestiga.com
604037828
Time Frame
Start Date: 2024-03-11
Estimated Completion Date: 2035-09
Participants
Target number of participants: 1272
Treatments
Experimental: DCB-based
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.
No_intervention: DES-based
Control group
Related Therapeutic Areas
Sponsors
Leads: Jorge Sanz Sanchez