Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI

Not Applicable

Recruiting

• Conditions: ST Elevation Myocardial Infarction

• Registration Number: NCT06353594
• Lead Sponsor: Jorge Sanz Sanchez

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-11
• Study First Submitted: 2024-03-14
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Primary Completion: 2026-09
• Study Completion: 2035-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1272

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Target lesion failure (TLF)	12 months	Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Incidence of bleeding	10 years	Physicians Assessment
Incidence of myocardial infarction	10 years	Physicians Assessment
Incidence of target lesion revascularization	10 years	Physicians Assessment
Incidence of stent thrombosis	10 years	Physicians Assessment
Incidence of acute vessel closure	10 years	Physicians Assessment
Incidence of cardiovascular death	10 years	Physicians Assessment
Incidence of all-cause death	10 years	Physicians Assessment
Incidence of stroke	10 years	Physicians Assessment
Incidence of acute kidney injury	10 years	Physicians Assessment

Trial Locations

Locations (15)

Hospital Universitario Y Politecnico La Fe; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Consorcio Hospitalario Provincial de Castellon; 🇪🇸 Castelló, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Madrid, Spain

Hospital Universitario Regional de Malaga; 🇪🇸 Málaga, Spain

Hospital Universitario de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario Virgen Del Rocio; 🇪🇸 Sevilla, Spain

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