Overview

This trial is active, not recruiting.

Conditions heart diseases, cardiovascular diseases, 3 vessel coronary artery disease
Treatments coronary stent, multi slice computed tomography, instantaneous wave-free ratio, fractional flow reserve, intravascular ultrasound
Sponsor ECRI bv
Collaborator Boston Scientific Corporation
Start date December 2013
End date December 2016
Trial size 454 participants
Trial identifier NCT02015832, ECRI-002

Summary

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
All patients (single arm study) will be receiving the SYNERGY™ Everolimus eluting stent (EES)
coronary stent SYNERGY™ EES
multi slice computed tomography MSCT
A coronary non-invasive Multi Slice Computed Tomography will be performed in patients
instantaneous wave-free ratio iFR
Pressure-derived, adenosine-free index on physiological assessment of stenosis severity
fractional flow reserve FFR
Pressure-derived index on physiological assessment of stenosis severity
intravascular ultrasound IVUS
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

Primary Outcomes

Measure
Composite of major adverse cardiac and cerebrovascular events (MACCE) rate compared to PCI arm of SYNTAX I
time frame: 1 year

Secondary Outcomes

Measure
Composite of all-cause death, cerebrovascular event (stroke), documented myocardial infarction compared to the PCI arm of SYNTAX I
time frame: 1 Year
Composite of cardiovascular death, documented target-vessel myocardial infarction and repeat target lesion revascularization at 1 year follow-up compared to the PCI arm of SYNTAX I
time frame: 1 Year
Rates of individual components of MACCE at 1 year
time frame: 1 Year
The composite of MACCE and its individual components of 2-5 years period of follow-up (patient reported)
time frame: 2-5 Years
Myocardial Infarction (MI) - according to Universal MI definition 2012
time frame: 1 Years
Stent Thrombosis - according to ARC definitions
time frame: 1 Years
Myocardial Infarction - according to Universal MI definition 2012
time frame: 2 Years
Myocardial Infarction - according to Universal MI definition 2012
time frame: 3 Years
Myocardial Infarction - according to Universal MI definition 2012
time frame: 4 Years
Myocardial Infarction - according to Universal MI definition 2012
time frame: 5 Years
Stent Thrombosis - according to ARC definitions
time frame: 2 Years
Stent Thrombosis - according to ARC definitions
time frame: 3 Years
Stent Thrombosis - according to ARC definitions
time frame: 4 Years
Stent Thrombosis - according to ARC definitions
time frame: 5 Years

Eligibility Criteria

Male or female participants at least 21 years old.

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 1. stable (Canadian Cardiovascular Society Class 1, 2, 3 or 4) angina pectoris 2. or unstable (Braunwald class) angina pectoris and ischemia 3. 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

Additional Information

Official title 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
Principal investigator Javier Escaned, MD
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by ECRI bv.