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Clinical Trials in Spain / NCT05599061
Active, not recruiting Not applicable

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

NCT05599061 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-01-30
Last updated
2026-07-15

Condition(s) studied

Coronary Artery DiseaseCoronary DiseaseIschemic Heart Disease

Investigational drug(s) / intervention(s)

FFR>0.80+ OCT with findings indicative of vulnerable plaqueFFR>0.80+ OCT with findings indicative of vulnerable plaque

FFR>0.80+ OCT with findings indicative of vulnerable plaque: Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI

FFR>0.80+ OCT with findings indicative of vulnerable plaque: OPTIMAL MEDICAL TREATMENT (OMT)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona
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

+ 9 more sites — see the full list on the official registry below.

More Fundación EPIC trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05599061 on ClinicalTrials.gov ↗ ← All trials in Spain