Phase
Condition
Myocardial Ischemia
Atherosclerosis
Chest Pain
Treatment
PCI revascularization strategy based FFR assessment
PCI revascularization strategy based on combined FFR and OCT assessment
Clinical Study ID
Ages 30-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients undergoing PCI, aged 30-80 years with any clinical presentation
Angiographic criteria: presence of ≥ 2 de novo target lesions* located in 2different native coronary arteries feasible for treatment with PCI (operator / Heartteam decision)
Angiographic criteria target lesion* (all criteria I-IV should be applicable):
I. DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation)
*Target lesions are either culprit MI lesions or lesions where FFR will be performed. Patients are eligible if they have ≥ 2 target lesions or one culprit and ≥ 1 target lesion.
Exclusion
Exclusion Criteria:
Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision)
Lesion located in a grafted segment or in a vein graft
In-stent restenosis lesions
Left main trifurcation
Left main lesion stand-alone (without other lesions)
Patients with severe tortuous lesions (where FFR and OCT is judged impossible ordangerous)
Chronic total occlusion
Spontaneous coronary dissection
Patients with severe valvular heart disease likely to require cardiac surgery withinthe next 2 years
Patients with left ventricle (LV) function less than 30%
Renal insufficiency (Glomerular Filtration Rate (GFR) < 29 ml/min/1.73m2; KidneyDisease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
Life expectancy less than 3 years
Study Design
Study Description
Connect with a study center
Monash Medical
Clayton,
AustraliaSite Not Available
McGill University Health Centre
Montreal,
CanadaSite Not Available
Hamilton Health Sciences
Ontario,
CanadaSite Not Available
Niagara Health System - St. Catherines Site
Ontario,
CanadaSite Not Available
Aarhus University Hospital
Aarhus,
DenmarkSite Not Available
North-Estonia Medical Centre
Tallinn,
EstoniaSite Not Available
Centre Hospitalier Régional Universitaire de Lille
Lille,
FranceSite Not Available
Clinique Louis Pasteur
Nancy,
FranceSite Not Available
Charité - Universitätsmedizin Berlin
Berlin,
GermanySite Not Available
Universitätsklinikum Frankfurt
Frankfurt,
GermanySite Not Available
Apex Heart Institute
Ahmedabad,
IndiaSite Not Available
Apollo Hospitals
Bangalore,
IndiaSite Not Available
Post Graduate Institute of Medical education and Research
Chandigarh,
IndiaSite Not Available
Humanitas Research Hospital
Milan,
ItalySite Not Available
Policlinico Universitario Fondazione Agostino Gemelli
Rome,
ItalySite Not Available
National University Corporation Institute of Science Tokyo
Bunkyo,
JapanSite Not Available
Yokohama City University Medical Center
Yokohama,
JapanSite Not Available
National Heart Institute
Kuala Lumpur,
MalaysiaSite Not Available
OLVG
Amsterdam,
NetherlandsSite Not Available
Albert Schweitzer Hospital
Dordrecht,
NetherlandsSite Not Available
Medisch Spectrum Twente
Enschede,
NetherlandsSite Not Available
Elisabeth-TweeSteden Hospital
Tilburg,
NetherlandsSite Not Available
Wellington Hospital
Wellington,
New ZealandSite Not Available
Medical University of Silesia
Katowice,
PolandSite Not Available
Jagiellonian University; John Paul II Hospital
Krakow,
PolandSite Not Available
University Hospital Krakow
Krakow,
PolandSite Not Available
Miedziowe Centrum Zdrowia
Lubin,
PolandSite Not Available
Warsaw Medical University
Warsaw,
PolandSite Not Available
Regional Specialist Hospital
Wroclaw,
PolandSite Not Available
C.C. Iliescu Institute of Cardiology Bucharest
Bucharest,
RomaniaSite Not Available
Different countries in Europe, Asia Pacific and Canada
Bucharest,
RomaniaActive - Recruiting
Nicolae Stăncioiu Heart Institute
Cluj-Napoca,
RomaniaSite Not Available
Clinic Hospital Targu Mures & S.C. Cardio Med SRL
Targu Mures,
RomaniaSite Not Available
Middle Slovak Institute of Cardiovascular Disease
Banska Bystrica,
SlovakiaSite Not Available
Hospital Bellvitge Barcelona
Barcelona,
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona,
SpainSite Not Available
Hospital Clinico San Carlos
Madrid,
SpainSite Not Available
Hospital Gregorio Marañón Madrid
Madrid,
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid,
SpainSite Not Available
Hospital de La Princesa
Madrid,
SpainSite Not Available
University Hospital La Paz
Madrid,
SpainSite Not Available
Marqués de Valdecilla University Hospital
Santander,
SpainSite Not Available
Hospital La Fe Valencia
Valencia,
SpainSite Not Available
Linköping University
Linköping,
SwedenSite Not Available
Lund University
Lund,
SwedenSite Not Available
Danderyd Hospital
Stockholm,
SwedenSite Not Available
Universitetssjukhuset Örebro
Örebro,
SwedenSite Not Available
Far Eastern Memorial Hospital
New Taipei City,
TaiwanSite Not Available
Cheng Hsin General Hospital
Taipei City,
TaiwanSite Not Available
National Taiwan University Hospital
Taipei City,
TaiwanSite Not Available
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