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Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial
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.
STEMI patients with multivessel disease planned for invasive evaluation of intermediate lesions (40-69% stenosis) are initially investigated with fractional flow reserve (FFR). Patients with FFR ≤ 0.80 are considered as screening failure and treated with PCI. Patients with FFR \> 0.80 are then investigated with optical coherence tomography (OCT). Patients without OCT findings of vulnerable plaque are treated with OMT and included in the OMT registry arm. Patients presenting with OCT characteristics of vulnerable plaque are included in the randomized trial comparing PCI with stent implantation plus OMT versus OMT.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 30, 2023
Primary Completion Date
December 1, 2028
Completion Date
December 1, 2028
Last Updated
January 29, 2026
600
ESTIMATED participants
FFR>0.80+ OCT with findings indicative of vulnerable plaque
OTHER
FFR>0.80+ OCT with findings indicative of vulnerable plaque
OTHER
Lead Sponsor
Fundación EPIC
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01311323