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

Last updated: October 6, 2024
Sponsor: Fundación EPIC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Angina

Circulation Disorders

Treatment

FFR>0.80+ OCT with findings indicative of vulnerable plaque

Clinical Study ID

NCT05599061
EPIC28-VULNERABLE
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients > 18 years.

  • Successful revascularization of the culprit lesion in patients undergoing coronaryangiography due to ST-segment elevation (> 1mm in > 2 contiguous leads, new leftbundle branch block, or true posterior MI with ST depression of >1mm in >2contiguous anterior leads) in the first 72 hours of the symptom's onset.

  • Multivessel coronary disease with non-culprit lesions located in different vesselsthan the culprit lesion and ranging from 40 to 69% of DS (visual estimated diameterstenosis ) by visual estimate planned for FFR-guided revascularization in stagedprocedure (>24 hours and <60 days after PCI of the culprit lesion).

  • Non-culprit lesions should be suitable for functional assessment with pressure wireand OCT catheter and should be suitable to be treated with a single 2.0 to 4.5 mmEES (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

Exclusion Criteria:

  • Inability to provide informed consent.

  • Female of childbearing potential (age <50 years and last menstruation within thelast 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 coronaryvessels with prior coronary revascularization (PCI or by-pass) or with distal vesselocclusion.

  • Patients with long, bifurcated, severely angulated or severely calcified non-culpritstudy 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 thepatient's life expectancy < 4 years.

  • Subject is currently participating in another clinical trial that has not yetcompleted its primary endpoint.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: FFR>0.80+ OCT with findings indicative of vulnerable plaque
Phase:
Study Start date:
January 30, 2023
Estimated Completion Date:
December 01, 2028

Study Description

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.

Connect with a study center

  • Hospital General Universitario de Albacete

    Albacete, 02006
    Spain

    Active - Recruiting

  • Hospital General Universitario Dr.Balmis

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital Universitari Sant Joan D'Alacant

    Alicante, 03550
    Spain

    Active - Recruiting

  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Universitari Vall Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de Santa Creu I Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11009
    Spain

    Active - Recruiting

  • Hospital General Universitario de Castellón

    Castellón De La Plana, 12004
    Spain

    Active - Recruiting

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005
    Spain

    Active - Recruiting

  • Hospital Universitario A Coruña

    Coruña, 15006
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia de Cordoba

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Hospital General Universitario de Elche

    Elche, 03203
    Spain

    Active - Recruiting

  • Hospital Universitario de Cabueñes

    Gijón, 33394
    Spain

    Active - Recruiting

  • Hospital Universitario de Girona Dr Trueta

    Girona, 17007
    Spain

    Active - Recruiting

  • Hospital Universitario San Cecilio

    Granada, 18016
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    Hospitalet de Llobregat, 08907
    Spain

    Active - Recruiting

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005
    Spain

    Active - Recruiting

  • Hospital Universitario de Leon

    León, 24001
    Spain

    Active - Recruiting

  • Hospital La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, 28222
    Spain

    Active - Recruiting

  • Hospital de Manises

    Manises, 46940
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Arrixaca

    Murcia, 30120
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33011
    Spain

    Active - Recruiting

  • Hospital Universitari Son Espases

    Palma De Mallorca, 07120
    Spain

    Active - Recruiting

  • Hospital Universitario de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitario de Donostia

    San Sebastián, 20014
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago De Compostela, 15706
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitari Joan Xxiii

    Tarragona, 43005
    Spain

    Active - Recruiting

  • Hospital Universitario Nuestra Señora de La Candelaria

    Tenerife, 38010
    Spain

    Active - Recruiting

  • Hospital Universitario de Torrevieja

    Torrevieja, 03186
    Spain

    Active - Recruiting

  • Hospital Universitario 12 Octubre

    Usera, 28041
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Active - Recruiting

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Hospital Universitari Miquel Servet

    Zaragoza, 50009
    Spain

    Active - Recruiting

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