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NCT05599061Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 15 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
609 (actual)
First submitted
25 Oct 2022
Start date
30 Jan 2023
Primary completion date
1 Dec 2028
Lead sponsor
Fundación EPIC
NCT number
NCT05599061

What you commit to

  • Study type: Interventional
  • Participants enrolled: 609
  • From 30 Jan 2023 to the primary completion date, 1 Dec 2028
  • 49 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Asthma or known history of bronchial hyper-reactivity.

Lab values

  • Chronic renal dysfunction with creatinine clearance \< 45 ml/min.

Age

  • Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
  • Severe comorbidities that in the opinion of the local investigators determine the patient's life expectancy \< 4 years.

Other

  • Inability to provide informed consent.
  • Known intolerance to aspirin, heparin, everolimus, contrast material.
  • Unresolved mechanical complication or cardiogenic shock at the staged procedure.
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (49)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Universitario A Coruña
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A CoruñaSpainUnknown status
Hospital General Universitario de Albacete
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AlbaceteSpainUnknown status
Hospital General Universitario Dr. Balmis
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AlicanteSpainUnknown status
Hospital Universitari Sant Joan D'Alacant
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AlicanteSpainUnknown status
Hospital Universitari Germans Trias i Pujol
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BadalonaSpainUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital del Mar
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BarcelonaSpainUnknown status
Hospital Universitari Vall Hebron
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BarcelonaSpainUnknown status
Hospital de Santa Creu I Sant Pau
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BarcelonaSpainUnknown status
Hospital Universitario Puerta del Mar
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CadizSpainUnknown status
Hospital General Universitario de Castellón
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CastellonSpainUnknown status
Hospital General Universitario de Ciudad Real
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Ciudad RealSpainUnknown status
Hospital Universitario Reina Sofia de Córdoba
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CórdobaSpainUnknown status
Hospital General Universitario de Elche
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ElcheSpainUnknown status
Hospital Universitario de Cabueñes
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GijónSpainUnknown status
Hospital Universitario de Girona Dr Trueta
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GironaSpainUnknown status
Hospital Universitario San Cecilio
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GranadaSpainUnknown status
Chu de Toledo
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GuadalajaraSpainUnknown status
Hospital Universitario Juan Ramon Jimenez
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HuelvaSpainUnknown status
H.U. de Gran Canaria-Dr. Negrin
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Las Palmas de Gran CanariaSpainUnknown status
H.I.U. Materno Infantil de Las Palmas
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Las Palmas de Gran CanariaSpainUnknown status
Hospital Universitario De Leon
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LeónSpainUnknown status
Hospital Universitari de Bellvitge
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Universitario Gregorio Marañón
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MadridSpainUnknown status
Hospital La Princesa
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MadridSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Universitario Puerta de Hierro
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MajadahondaSpainUnknown status
Hospital de Manises
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ManisesSpainUnknown status
Hospital de Mérida
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MéridaSpainUnknown status
Hospital Universitario Virgen Arrixaca
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MurciaSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Hospital Universitari Son Espases
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Palma de MallorcaSpainUnknown status
Hospital Universitario de Navarra
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PamplonaSpainUnknown status
Hospital Clinico Universitario de Salamanca
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SalamancaSpainUnknown status
Hospital Universitario de Donostia
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San SebastiánSpainUnknown status
Hospital Universitario Nuestra Señora de la Candelaria
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Santa Cruz de TenerifeSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
Hospital Clínico Universitario de Santiago de Compostela
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Santiago de CompostelaSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Hospital Universitari Joan XXIII
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TarragonaSpainUnknown status
Hospital Universitari MutuaTerrassa
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TerrassaSpainUnknown status
Hospital Universitario de Torrevieja
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TorreviejaSpainUnknown status
Hospital Universitario 12 Octubre
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UseraSpainUnknown status
Hospital Universitari i Politécnic La Fe
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ValenciaSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
Hospital General Universitario de Valencia
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ValenciaSpainUnknown status
Hospital Clínico Universitario de Valladolid
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ValladolidSpainUnknown status
Hospital Universitari Miquel Servet
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ZaragozaSpainUnknown status
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.