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

Status: Recruiting
Location: See all (46) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitario A Coruña
RECRUITING
A Coruña
Hospital General Universitario de Albacete
RECRUITING
Albacete
Hospital General Universitario Dr.Balmis
RECRUITING
Alicante
Hospital Universitari Sant Joan D'Alacant
RECRUITING
Alicante
Hospital Universitari Germans Trias I Pujol
RECRUITING
Badalona
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital de Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Del Mar
RECRUITING
Barcelona
Hospital Universitari Vall Hebron
RECRUITING
Barcelona
Hospital Universitario Puerta Del Mar
RECRUITING
Cadiz
Hospital General Universitario de Castellón
RECRUITING
Castellon
Hospital General Universitario de Ciudad Real
RECRUITING
Ciudad Real
Hospital Universitario Reina Sofia de Cordoba
RECRUITING
Córdoba
Hospital General Universitario de Elche
RECRUITING
Elche
Hospital Universitario de Cabueñes
RECRUITING
Gijón
Hospital Universitario de Girona Dr Trueta
RECRUITING
Girona
Hospital Universitario San Cecilio
RECRUITING
Granada
Hospital Universitario Juan Ramon Jimenez
RECRUITING
Huelva
Hospital Universitari de Bellvitge
RECRUITING
L'hospitalet De Llobregat
H.U. de Gran Canaria-Dr. Negrin
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario de Leon
RECRUITING
León
Hospital La Princesa
RECRUITING
Madrid
Hospital Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
RECRUITING
Majadahonda
Hospital de Manises
RECRUITING
Manises
Hospital de Merida
RECRUITING
Mérida
Hospital Universitario Virgen Arrixaca
RECRUITING
Murcia
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Universitari Son Espases
RECRUITING
Palma De Mallorca
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Clinico Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario de Donostia
RECRUITING
San Sebastián
Hospital Universitario Nuestra Señora de La Candelaria
RECRUITING
Santa Cruz De Tenerife
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Clinico Universitario de Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Universitari Joan Xxiii
RECRUITING
Tarragona
Hospital Universitario de Torrevieja
RECRUITING
Torrevieja
Hospital Universitario 12 Octubre
RECRUITING
Usera
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Hospital General Universitario de Valencia
RECRUITING
Valencia
Hospital Universitari I Politecnic La Fe
RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Hospital Clinico Universitario Lozano Blesa
RECRUITING
Zaragoza
Hospital Universitari Miquel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Josep Gomez-Lara, MD, PhD
gomezjosep@hotmail.com
0034677255399
Backup
FUNDACION EPIC
iepic@fundacionepic.org
0034987225638
Time Frame
Start Date: 2023-01-30
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 600
Treatments
Experimental: Optimal Medical Treatment (OMT) + PCI
Active_comparator: Optimal Medical Treatment (OMT)
Sponsors
Leads: Fundación EPIC
Collaborators: Abbott

This content was sourced from clinicaltrials.gov