NCT06353594 Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI
| NCT ID | NCT06353594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario La Fe |
| Condition | ST Elevation Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,272 participants |
| Start Date | 2024-03-11 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,272 participants in total. It began in 2024-03-11 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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.
Contact & Investigator
Jorge Sanz Sánchez, PI
PRINCIPAL INVESTIGATOR
Hospital Universitario La Fe
Frequently Asked Questions
Who can join the NCT06353594 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ST Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06353594 currently recruiting?
Yes, NCT06353594 is actively recruiting participants. Contact the research team at naiara@pinvestiga.com for enrollment information.
Where is the NCT06353594 trial being conducted?
This trial is being conducted at Huelva, Spain, Valencia, Spain, A Coruña, Spain, Burgos, Spain and 11 additional locations.
Who is sponsoring the NCT06353594 clinical trial?
NCT06353594 is sponsored by Hospital Universitario La Fe. The principal investigator is Jorge Sanz Sánchez, PI at Hospital Universitario La Fe. The trial plans to enroll 1,272 participants.