Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05599061

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

Led by Fundación EPIC · Updated on 2026-01-29

600

Participants Needed

49

Research Sites

304 weeks

Total Duration

On this page

Sponsors

F

Fundación EPIC

Lead Sponsor

A

Abbott

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old
  • Successful revascularization of culprit lesion after ST-elevation myocardial infarction within 72 hours of symptom onset
  • Multivessel coronary disease with non-culprit lesions showing 40 to 69% diameter stenosis planned for FFR-guided revascularization between 24 hours and 60 days after PCI
  • Non-culprit lesions suitable for pressure wire and OCT assessment and treatable with a single 2.0 to 4.5 mm everolimus-eluting stent
  • Agreement to avoid participation in other clinical trials for 4 years after inclusion
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Female of childbearing potential under 50 years without tubal ligation, ovariectomy, or hysterectomy
  • Known intolerance to aspirin, heparin, everolimus, or contrast material
  • Unresolved mechanical complication or cardiogenic shock at staged procedure
  • Non-culprit lesions in left main coronary artery, vessels with prior revascularization, or with distal vessel occlusion
  • Lesions unsuitable for single everolimus-eluting stent implantation due to length, bifurcation, angulation, or calcification
  • History of asthma or bronchial hyper-reactivity
  • Chronic kidney dysfunction with creatinine clearance below 45 ml/min
  • Severe comorbidities limiting life expectancy to less than 4 years
  • Currently enrolled in another clinical trial that has not completed its primary endpoint

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 49 locations

1

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Actively Recruiting

2

Hospital Universitario A Coruña

A Coruña, Spain, 15006

Actively Recruiting

3

Hospital General Universitario de Albacete

Albacete, Spain, 02006

Actively Recruiting

4

Hospital General Universitario Dr.Balmis

Alicante, Spain, 03010

Actively Recruiting

5

Hospital Universitari Sant Joan D'Alacant

Alicante, Spain, 03550

Actively Recruiting

6

Hospital Universitari Germans Trias I Pujol

Badalona, Spain, 08916

Actively Recruiting

7

Hospital Del Mar

Barcelona, Spain, 08003

Actively Recruiting

8

Hospital de Santa Creu I Sant Pau

Barcelona, Spain, 08025

Actively Recruiting

9

Hospital Universitari Vall Hebron

Barcelona, Spain, 08035

Actively Recruiting

10

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

11

Hospital Universitario Puerta Del Mar

Cadiz, Spain, 11009

Actively Recruiting

12

Hospital General Universitario de Castellón

Castellon, Spain, 12004

Actively Recruiting

13

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain, 13005

Actively Recruiting

14

Hospital Universitario Reina Sofia de Cordoba

Córdoba, Spain, 14004

Actively Recruiting

15

Hospital General Universitario de Elche

Elche, Spain, 03203

Actively Recruiting

16

Hospital Universitario de Cabueñes

Gijón, Spain, 33394

Actively Recruiting

17

Hospital Universitario de Girona Dr Trueta

Girona, Spain, 17007

Actively Recruiting

18

Hospital Universitario San Cecilio

Granada, Spain, 18016

Actively Recruiting

19

Chu de Toledo

Guadalajara, Spain

Actively Recruiting

20

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain, 21005

Actively Recruiting

21

H.U. de Gran Canaria-Dr. Negrin

Las Palmas de Gran Canaria, Spain, 35010

Actively Recruiting

22

H.I.U. Materno Infantil de Las Palmas

Las Palmas de Gran Canaria, Spain, 35016

Actively Recruiting

23

Hospital Universitario de Leon

León, Spain, 24001

Actively Recruiting

24

Hospital La Princesa

Madrid, Spain, 28006

Actively Recruiting

25

Hospital Universitario Gregorio Marañon

Madrid, Spain, 28007

Actively Recruiting

26

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

27

Hospital Universitario Puerta de Hierro

Majadahonda, Spain, 28222

Actively Recruiting

28

Hospital de Manises

Manises, Spain, 46940

Actively Recruiting

29

Hospital de Merida

Mérida, Spain, 06800

Actively Recruiting

30

Hospital Universitario Virgen Arrixaca

Murcia, Spain, 30120

Actively Recruiting

31

Hospital Universitario Central de Asturias

Oviedo, Spain, 33011

Actively Recruiting

32

Hospital Universitari Son Espases

Palma de Mallorca, Spain, 07120

Actively Recruiting

33

Hospital Universitario de Navarra

Pamplona, Spain, 31008

Actively Recruiting

34

Hospital Clinico Universitario de Salamanca

Salamanca, Spain, 37007

Actively Recruiting

35

Hospital Universitario de Donostia

San Sebastián, Spain, 20014

Actively Recruiting

36

Hospital Universitario Nuestra Señora de La Candelaria

Santa Cruz de Tenerife, Spain, 38010

Actively Recruiting

37

Hospital Universitario Marqués de Valdecilla

Santander, Spain, 39008

Actively Recruiting

38

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Actively Recruiting

39

Hospital Universitario Virgen Del Rocio

Seville, Spain, 41013

Actively Recruiting

40

Hospital Universitari Joan Xxiii

Tarragona, Spain, 43005

Actively Recruiting

41

Hospital Universitari MútuaTerrassa

Terrassa, Spain, 08221

Actively Recruiting

42

Hospital Universitario de Torrevieja

Torrevieja, Spain, 03186

Actively Recruiting

43

Hospital Universitario 12 Octubre

Usera, Spain, 28041

Actively Recruiting

44

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Actively Recruiting

45

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Actively Recruiting

46

Hospital Universitari I Politecnic La Fe

Valencia, Spain, 46026

Actively Recruiting

47

Hospital Clínico Universitario de Valladolid

Valladolid, Spain, 47003

Actively Recruiting

48

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain, 50009

Actively Recruiting

49

Hospital Universitari Miquel Servet

Zaragoza, Spain, 50009

Actively Recruiting

Loading map...

Research Team

J

Josep Gomez-Lara, MD, PhD

CONTACT

F

FUNDACION EPIC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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