Phase
Condition
Atherosclerosis
Heart Disease
Coronary Artery Disease
Treatment
FFR guided revascularization
vFFR guided revascularization
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The patient must be ≥18 years of age
- Presenting with silent ischemia, stable angina, or non-ST-elevation acute coronarysyndrome (NSTE-ACS)
- Coronary artery disease with at least one native artery in which the stenosis severityis questionable (typically 30-80% stenosis)
- FFR assessment and vFFR assessment feasible
- The patient is willing and able to cooperate with study procedures and follow-up untilstudy completion
- Subject is able to confirm understanding of risks, benefits and treatment alternativesand he/she provides informed consent prior to any protocol-related procedure, asapproved by the appropriate Ethics Committee
Exclusion
Exclusion Criteria:
- ST-elevation myocardial infarction (STEMI) at presentation
- Cardiogenic shock or severe hemodynamic instability at the time of intervention (heartrate<50 beats per minute, systolic blood pressure <90mmHg) or use of left ventricularassist device
- Any target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow <3.
- Presence of thrombus in intermediate target lesion.
- Known untreated severe valvular heart disease
- Target lesion is located in or supplied by an arterial or venous bypass graft
- History of cardiac allograft transplantation
- Aorto-ostial lesions with an estimated diameter stenosis >50%
- Severe tortuosity precluding the acquisitions of 2 orthogonal projections of thetarget vessel with minimal overlap or foreshortening.
- Absolute contraindications or allergy that cannot be pre-medicated, to iodinatedcontrast or adenosine
- Non-cardiac co-morbidities with a life expectancy less than 1 year
- Currently participating in another trial that is not yet at its primary endpoint. Thepatient is not allowed to participate in another investigational device or drug studyuntil the trial primary endpoint time point is achieved and may only be enrolled oncein the study
- Women of childbearing potential who do not have a negative pregnancy test within 24hours before the procedure
- Subject belongs to a vulnerable population (per Investigator's judgment) or subjectunable to read or write
Study Design
Study Description
Connect with a study center
Clinique St Martin
Caen,
FranceActive - Recruiting
Institut Cardiovasculaire de Grenoble
Grenoble,
FranceSite Not Available
CHU LILLE - Institut Cœur Poumon
Lille,
FranceActive - Recruiting
Hôpital de la Croix Rousse, hospices civils de lyon
Lyon,
FranceActive - Recruiting
Hôpital Privé Jacques Cartier
Massy,
FranceSite Not Available
Clinique les Fontaines
Melun,
FranceActive - Recruiting
Clinique Saint Hilaire
Rouen,
FranceActive - Recruiting
Herz- und Diabeteszentrum NRW
Bad Oeynhausen,
GermanyActive - Recruiting
Charité- Campus Benjamin Franklin
Berlin,
GermanyActive - Recruiting
Unfallkrankenhaus Berlin
Berlin,
GermanyActive - Recruiting
Universitatsklinikum Dusseldorf
Düsseldorf,
GermanySite Not Available
Marienhaus Klinikum
Neuwied,
GermanyActive - Recruiting
SHG Klinik Völklingen
Völklingen,
GermanyActive - Recruiting
Mater Private Cork
Cork,
IrelandActive - Recruiting
Beaumont Hospital
Dublin,
IrelandSite Not Available
Mater Private Dublin
Dublin,
IrelandActive - Recruiting
St James Hospital
Dublin,
IrelandActive - Recruiting
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo,
ItalyActive - Recruiting
AOU di Ferrara (Ospedale Sant'Anna)
Cona,
ItalyActive - Recruiting
Cardiologia Ospedale Dell' Angelo
Mestre,
ItalyActive - Recruiting
Humanitas Research Hospital
Milan,
ItalyActive - Recruiting
Policlinico San Donato
Milan,
ItalyActive - Recruiting
Pineta Grande Hospital
Naples,
ItalySite Not Available
Ospedale Maggiore della Carità
Novara,
ItalyActive - Recruiting
AOU Verona
Verona,
ItalySite Not Available
Cardiologia Ospedale San Bortolo
Vicenza,
ItalyActive - Recruiting
Tergooi MC
Blaricum,
NetherlandsActive - Recruiting
Amphia Ziekenhuis
Breda,
NetherlandsActive - Recruiting
Albert Schweitzer
Dordrecht,
NetherlandsActive - Recruiting
Erasmus University Medical Center
Rotterdam,
NetherlandsActive - Recruiting
UMCU
Utrecht,
NetherlandsActive - Recruiting
Hospital Univeritario A Coruna
A Coruña,
SpainActive - Recruiting
Hospital Clinic
Barcelona,
SpainActive - Recruiting
Hospital del Mar
Barcelona,
SpainActive - Recruiting
Hospital Universitario de Leon
León,
SpainSite Not Available
Hospital Universitario de la Princesa
Madrid,
SpainActive - Recruiting
La Paz
Madrid,
SpainActive - Recruiting
Hospital Universitario Central de Asturias
Oviedo,
SpainActive - Recruiting
Hospital Clinico Universitario de Valladolid
Valladolid,
SpainActive - Recruiting
Royal Victoria Hospital
Belfast,
United KingdomSite Not Available
Royal Sussex County Hospital
Brighton,
United KingdomActive - Recruiting
Golden Jubilee National Hospital
Glasgow,
United KingdomActive - Recruiting
John Radcliffe Hospital
Oxford,
United KingdomActive - Recruiting
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