A single-arm trial to evaluate 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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 54

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 a) stable angina pectoris, b) unstable angina pectoris and ischemia or c) patients with atypical chest pain or those who are asymptomatic provided they have myocardial ischemia; 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is a composite of MACCE at 1 year follow-up compared to<br /><br>PCI arm of the SYNTAX I Trial (acting as a historical control)<br /><br><br /><br>MACCE is defined as: all-cause death; cerebrovascular event (stroke);<br /><br>documented myocardial infarction or repeat revascularization</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints of this study are to assess:<br /><br><br /><br>* Composite of all-cause death, cerebrovascular event (stroke), documented<br /><br>myocardial infarction at 1 year follow-up compared to the PCI arm<br /><br>of SYNTAX I;<br /><br>* Composite of cardiovascular death, documented target-vessel myocardial<br /><br>infarction and repeat target lesion revascularization at 1 year<br /><br>follow-up compared to the PCI arm of SYNTAX I;<br /><br>* Rates of individual components of MACCE (all-cause death, cerebrovascular<br /><br>event (stroke), documented myocardial infarction and repeat<br /><br>revascularization) at 1 year;<br /><br>* The composite of MACCE rate and its individual components at 2-5 years<br /><br>follow-up (patient reported);<br /><br>* Myocardial Infarction * according to Universal MI definition 2012 at all<br /><br>timepoints;<br /><br>* Stent Thrombosis * according to ARC definitions at all timepoints;</p><br>