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
- Diseases
- Coronary artery disease
- 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
Sites (49)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital General Universitario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Unknown status |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitari Sant Joan D'Alacant Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de Santa Creu I Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| Hospital General Universitario de Castellón Coordinator of this site? Confirm its status | Castellon | Spain | Unknown status |
| Hospital General Universitario de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Unknown status |
| Hospital Universitario Reina Sofia de Córdoba Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Unknown status |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Unknown status |
| Hospital Universitario de Girona Dr Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital Universitario San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Chu de Toledo Coordinator of this site? Confirm its status | Guadalajara | Spain | Unknown status |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| H.U. de Gran Canaria-Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| H.I.U. Materno Infantil de Las Palmas Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
| Hospital Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital La Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital de Manises Coordinator of this site? Confirm its status | Manises | Spain | Unknown status |
| Hospital de Mérida Coordinator of this site? Confirm its status | Mérida | Spain | Unknown status |
| Hospital Universitario Virgen Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitari Son Espases Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Clinico Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hospital Universitario de Donostia Coordinator of this site? Confirm its status | San Sebastián | Spain | Unknown status |
| Hospital Universitario Nuestra Señora de la Candelaria Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Clínico Universitario de Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitari Joan XXIII Coordinator of this site? Confirm its status | Tarragona | Spain | Unknown status |
| Hospital Universitari MutuaTerrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
| Hospital Universitario de Torrevieja Coordinator of this site? Confirm its status | Torrevieja | Spain | Unknown status |
| Hospital Universitario 12 Octubre Coordinator of this site? Confirm its status | Usera | Spain | Unknown status |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Hospital Universitari Miquel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.