Phase
Condition
Coronary Artery Disease
Angina
Circulation Disorders
Treatment
FFR>0.80+ OCT with findings indicative of vulnerable plaque
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Hospital General Universitario de Albacete
Albacete, 02006
SpainActive - Recruiting
Hospital General Universitario Dr.Balmis
Alicante, 03010
SpainActive - Recruiting
Hospital Universitari Sant Joan D'Alacant
Alicante, 03550
SpainActive - Recruiting
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital Del Mar
Barcelona, 08003
SpainActive - Recruiting
Hospital Universitari Vall Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital de Santa Creu I Sant Pau
Barcelona, 08025
SpainActive - Recruiting
Hospital Universitario Puerta Del Mar
Cadiz, 11009
SpainActive - Recruiting
Hospital General Universitario de Castellón
Castellón De La Plana, 12004
SpainActive - Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
SpainActive - Recruiting
Hospital Universitario A Coruña
Coruña, 15006
SpainActive - Recruiting
Hospital Universitario Reina Sofia de Cordoba
Córdoba, 14004
SpainActive - Recruiting
Hospital General Universitario de Elche
Elche, 03203
SpainActive - Recruiting
Hospital Universitario de Cabueñes
Gijón, 33394
SpainActive - Recruiting
Hospital Universitario de Girona Dr Trueta
Girona, 17007
SpainActive - Recruiting
Hospital Universitario San Cecilio
Granada, 18016
SpainActive - Recruiting
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, 08907
SpainActive - Recruiting
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005
SpainActive - Recruiting
Hospital Universitario de Leon
León, 24001
SpainActive - Recruiting
Hospital La Princesa
Madrid, 28006
SpainActive - Recruiting
Hospital Universitario Gregorio Marañon
Madrid, 28007
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, 28222
SpainActive - Recruiting
Hospital de Manises
Manises, 46940
SpainActive - Recruiting
Hospital Universitario Virgen Arrixaca
Murcia, 30120
SpainActive - Recruiting
Hospital Universitario Central de Asturias
Oviedo, 33011
SpainActive - Recruiting
Hospital Universitari Son Espases
Palma De Mallorca, 07120
SpainActive - Recruiting
Hospital Universitario de Navarra
Pamplona, 31008
SpainActive - Recruiting
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Hospital Universitario de Donostia
San Sebastián, 20014
SpainActive - Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
SpainActive - Recruiting
Hospital Clinico Universitario de Santiago de Compostela
Santiago De Compostela, 15706
SpainActive - Recruiting
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitari Joan Xxiii
Tarragona, 43005
SpainActive - Recruiting
Hospital Universitario Nuestra Señora de La Candelaria
Tenerife, 38010
SpainActive - Recruiting
Hospital Universitario de Torrevieja
Torrevieja, 03186
SpainActive - Recruiting
Hospital Universitario 12 Octubre
Usera, 28041
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainActive - Recruiting
Hospital General Universitario de Valencia
Valencia, 46014
SpainActive - Recruiting
Hospital Universitari I Politecnic La Fe
Valencia, 46026
SpainActive - Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
SpainActive - Recruiting
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
SpainActive - Recruiting
Hospital Universitari Miquel Servet
Zaragoza, 50009
SpainActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.