Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization

Korábbi kezelés

• Currently participating in another trial that is not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study

Más betegség

• ST-elevation myocardial infarction (STEMI) at presentation
• Cardiogenic shock or severe hemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg) or use of left ventricular assist device
• Any target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow <3.
• Known untreated severe valvular heart disease
• History of cardiac allograft transplantation
• Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or adenosine
• Non-cardiac co-morbidities with a life expectancy less than 1 year

Egyéb

• Presence of thrombus in intermediate target lesion.
• Target lesion is located in or supplied by an arterial or venous bypass graft
• Aorto-ostial lesions with an estimated diameter stenosis >50%
• Severe tortuosity precluding the acquisitions of 2 orthogonal projections of the target vessel with minimal overlap or foreshortening.
• Women of childbearing potential who do not have a negative pregnancy test within 24 hours before the procedure
• Subject belongs to a vulnerable population (per Investigator's judgment) or subject unable to read or write

• The patient must be ≥18 years of age
• Presenting with silent ischemia, stable angina, or non-ST-elevation acute coronary syndrome (NSTE-ACS)
• Coronary artery disease with at least one native artery in which the stenosis severity is 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 until study completion
• Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee