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RECRUITING

NCT05599061

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial

Sponsor: Fundación EPIC

View on ClinicalTrials.gov

Summary

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.

Official title: Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2023-01-30

Completion Date

2028-12-01

Last Updated

2026-01-29

Healthy Volunteers

Conditions

Coronary Artery Disease Coronary Disease Ischemic Heart Disease

Interventions

OTHER

FFR>0.80+ OCT with findings indicative of vulnerable plaque

Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI

OTHER

FFR>0.80+ OCT with findings indicative of vulnerable plaque

OPTIMAL MEDICAL TREATMENT (OMT)

Inclusion Criteria: * Patients \> 18 years. * Successful revascularization of the culprit lesion in patients undergoing coronary angiography due to ST-segment elevation (\> 1mm in \> 2 contiguous leads, new left bundle branch block, or true posterior MI with ST depression of \>1mm in \>2 contiguous anterior leads) in the first 72 hours of the symptom's onset. * Multivessel coronary disease with non-culprit lesions located in different vessels than the culprit lesion and ranging from 40 to 69% of DS (visual estimated diameter stenosis ) by visual estimate planned for FFR-guided revascularization in staged procedure (\>24 hours and \<60 days after PCI of the culprit lesion). * Non-culprit lesions should be suitable for functional assessment with pressure wire and OCT catheter and should be suitable to be treated with a single 2.0 to 4.5 mm EES (everolimus-eluting stent ). * Subject agrees to not participate in any other clinical trial study for a period of 4 years following the inclusion in the study. * Informed consent signed. Exclusion Criteria: * Inability to provide informed consent. * Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy. * Known intolerance to aspirin, heparin, everolimus, contrast material. * Unresolved mechanical complication or cardiogenic shock at the staged procedure. * Non-culprit study lesions located in the left main coronary artery or in coronary vessels with prior coronary revascularization (PCI or by-pass) or with distal vessel occlusion. * Patients with long, bifurcated, severely angulated or severely calcified non-culprit study lesions non suitable to be treated with a single EES implantation. * Asthma or known history of bronchial hyper-reactivity. * Chronic renal dysfunction with creatinine clearance \< 45 ml/min. * Severe comorbidities that in the opinion of the local investigators determine the patient's life expectancy \< 4 years. * Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Locations (49)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario A Coruña

A Coruña, Spain

Hospital General Universitario de Albacete

Albacete, Spain

Hospital General Universitario Dr.Balmis

Alicante, Spain

Hospital Universitari Sant Joan D'Alacant

Alicante, Spain

Hospital Universitari Germans Trias I Pujol

Badalona, Spain

Hospital Del Mar

Barcelona, Spain

Hospital de Santa Creu I Sant Pau

Barcelona, Spain

Hospital Universitari Vall Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario Puerta Del Mar

Cadiz, Spain

Hospital General Universitario de Castellón

Castellon, Spain

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

Hospital Universitario Reina Sofia de Cordoba

Córdoba, Spain

Hospital General Universitario de Elche

Elche, Spain

Hospital Universitario de Cabueñes

Gijón, Spain

Hospital Universitario de Girona Dr Trueta

Girona, Spain

Hospital Universitario San Cecilio

Granada, Spain

Chu de Toledo

Guadalajara, Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain

H.U. de Gran Canaria-Dr. Negrin

Las Palmas de Gran Canaria, Spain

H.I.U. Materno Infantil de Las Palmas

Las Palmas de Gran Canaria, Spain

Hospital Universitario de Leon

León, Spain

Hospital La Princesa

Madrid, Spain

Hospital Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Spain

Hospital de Manises

Manises, Spain

Hospital de Merida

Mérida, Spain

Hospital Universitario Virgen Arrixaca

Murcia, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Hospital Universitario de Donostia

San Sebastián, Spain

Hospital Universitario Nuestra Señora de La Candelaria

Santa Cruz de Tenerife, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Universitari Joan Xxiii

Tarragona, Spain

Hospital Universitari MútuaTerrassa

Terrassa, Spain

Hospital Universitario de Torrevieja

Torrevieja, Spain

Hospital Universitario 12 Octubre

Usera, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Hospital Universitari I Politecnic La Fe

Valencia, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

Hospital Universitari Miquel Servet

Zaragoza, Spain

Clinical Research Directory

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (49)