Clinical study that aims to evaluate a new strategy using the SYNTAX II Score calculator in the functional assessment of patients with new coronary 3-vessel-disease who undergo percutaneous coronary intervention (PCI)
The purpose of the SYNTAX II Trial is to investigate the management of de-novo 3-vessel-disease in order to prospectively assess which patients would have at least comparable short and long term clinical outcomes between coronary artery bypass graft and percutaneous coronary intervention (PCI), using contemporary PCI practice. In SYNTAX II the effectiveness of a contemporary stent (designed with thinner struts, biocompatible and biodegradable polymer, and a limus based drug), the use of pressure wire assessment of lesions to allow for ischemia-driven revascularisation, intravascular ultrasound (IVUS) guidance to optimise drug eluting stent deployment, and the treatment of (chronic) total occlusion lesions with contemporary techniques, will be compared against PCI practice in the original SYNTAX trial. The proposed study would involve the SYNTAX Score II to prospectively recruit subjects on the grounds of patient safety
Study Type
OBSERVATIONAL
Enrollment
454
A coronary non-invasive Multi Slice Computed Tomography will be performed in patients
Pressure-derived, adenosine-free index on physiological assessment of stenosis severity
Research Center NL007
Amsterdam, North Holland, Netherlands
Research Center NL001
Rotterdam, South Holland, Netherlands
Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization
Time frame: 1 year
Number of Participants With All-cause Death, Stroke, or Myocardial Infarction
Safety endpoint
Time frame: 1 Year
Number of Participants With All-cause Death
All-cause death
Time frame: 1 Year
Number of Participants With Stroke
Stroke
Time frame: 1 Year
Number of Participants With Myocardial Infarction
Any myocardial infarction
Time frame: 1 year
Number of Participants With Revascularization
Any coronary revascularization
Time frame: 1 Years
Number of Participants With Definite Stent Thrombosis
Stent Thrombosis - according to ARC definitions. Definite ST can be confirmed with 1) angiography (the presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest; New ischemic ECG changes that suggest acute ischemia; Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous MI); Non-occlusive thrombus or Occlusive thrombus; or 2) Pathological confirmation (evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy).
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Pressure-derived index on physiological assessment of stenosis severity
Allows the application of ultrasound technology to see from inside blood vessels out through the surrounding blood column, visualizing the inner wall of blood vessels
Research Center PL008
Bielsko-Biala, Poland
Research Center PL012
Katowice, Poland
Research Center PL010
Krakow, Poland
Research Center PL004
Poznan, Poland
Research Center ES009
Santander, Cantabria, Spain
Research Center ES001
Barcelona, Catalonia, Spain
Research Center ES004
Vigo, Galicia, Spain
Research Center ES007
Madrid, Madrid, Spain
...and 12 more locations
Time frame: 1 Year
Number of Participants With Probable Stent Thrombosis
Stent Thrombosis - according to ARC definitions. Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: 1) Any unexplained death within the first 30 days; 2) Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time frame: 1 year