Trial Evaluating New Strategy in the Functional Assessment of 3-vessel Disease Using SYNTAXII Score in Patients With PCI

Study Overview
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Brief Summary
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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)

Detailed Description
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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

Official Title
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Single-arm Trial Evaluating the Effectiveness of PCI of de Novo 3-vessel Disease Applying the SYNTAX Score II With Pressure Wire Functional Assessment and IVUS Guidance, Using an Everolimus-eluting Stent With Biodegradable Abluminal Coating

Conditions
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Heart Diseases, Cardiovascular Diseases, 3 Vessel Coronary Artery Disease

Intervention / Treatment
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* Device: Coronary stent
* Radiation: Multi Slice Computed Tomography
* Device: instantaneous wave-free ratio
* Device: Fractional flow reserve
* Device: Intravascular Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 1 stenosis, angiographic, visually determined de novo lesions with more than 50 percent diameter stenosis in all 3 major epicardial territories. These are left descending coronary artery (LAD) and or side branch, proximal circumflex coronary artery (LCX) and or side branch, right descending coronary artery (RCA) and or side branch which are supplying viable myocardium without left main involvement. Patients with ostial LAD or ostial CX Medina 0,0,1 or Medina 0,1,0 may be enrolled Patients with hypoplastic RCA with absence of descending posterior and presence of a lesion in the LAD and CX territories may be included in the trial as a 3 vessel disease equivalent Vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram Patients with stable (Canadian Cardiovascular Society Class 1, 2, 3 or 4) angina pectoris or unstable (Braunwald class) angina pectoris and ischemia or patients with atypical chest pain or those who are asymptomatic provided they have myocardial ischemia, for example treadmill exercise test, radionuclide scintigraphy, stress echocardiography All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site Signed Heart Team Decision Form between local cardiologist and surgeon that the selected case meets all of the inclusion and exclusion criteria Exclusion Criteria: Under the age of 21 years Known pregnancy at time of enrolment. Female of childbearing potential, and last menstruation within the last 12 months, who are not taking adequate contraceptives. Female who is breastfeeding at time of enrolment Prior PCI or CABG Ongoing acute myocardial infarction and enzymes (CKMB) more than 2x upper limit of normal Concomitant cardiac valve disease requiring surgical therapy, reconstruction or replacement Single or two-vessel disease at time of Heart Team consensus Participation or planned participation in another cardiovascular clinical study before one year follow up is completed Mental condition, psychiatric or organ cerebral disease, rendering the subject unable to understand the nature, scope, and possible consequences of the study or mental retardation or language barrier such that the patient is unable to give informed consent and potential for non-compliance towards the requirement in the study protocol

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Percutaneous Coronary Intervention<br>All patients (single arm study) will be receiving the SYNERGY™ Everolimus eluting stent (EES) | Device: Coronary stent<br> <br> * Other names: SYNERGY™ EES;Radiation: Multi Slice Computed Tomography<br>* A coronary non-invasive Multi Slice Computed Tomography will be performed in patients<br>* Other names: MSCT;Device: instantaneous wave-free ratio<br>* Pressure-derived, adenosine-free index on physiological assessment of stenosis severity<br>* Other names: iFR;Device: Fractional flow reserve<br>* Pressure-derived index on physiological assessment of stenosis severity<br>* Other names: FFR;Device: Intravascular Ultrasound<br>* 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<br>* Other names: IVUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With All-cause Death, Stroke, or Myocardial Infarction | Safety endpoint | 1 Year | 
| Number of Participants With All-cause Death | All-cause death | 1 Year | 
| Number of Participants With Stroke | Stroke | 1 Year | 
| Number of Participants With Myocardial Infarction | Any myocardial infarction | 1 year | 
| Number of Participants With Revascularization | Any coronary revascularization | 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). | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SYNTAX II Score, Pressure wires, instantaneous wave-free ratio, fractional flow reserve, intravascular ultrasound, Drug eluting stents, Stents, Angioplasty, multi slice computed tomography