A Trial to Evaluate a New Strategy in the Functional Assessment of 3-vessel Disease Using the SYNTAX II Score in Patients Treated With PCI

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by ECRI bv
Sponsor:
Collaborators:
Boston Scientific Corporation
Volcano Corporation
Information provided by (Responsible Party):
ECRI bv
ClinicalTrials.gov Identifier:
NCT02015832
First received: December 13, 2013
Last updated: August 21, 2014
Last verified: April 2014

December 13, 2013
August 21, 2014
December 2013
December 2015   (final data collection date for primary outcome measure)
Composite of major adverse cardiac and cerebrovascular events (MACCE) rate compared to PCI arm of SYNTAX I [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization
Same as current
Complete list of historical versions of study NCT02015832 on ClinicalTrials.gov Archive Site
  • Composite of all-cause death, cerebrovascular event (stroke), documented myocardial infarction compared to the PCI arm of SYNTAX I [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Rates of individual components of MACCE at 1 year [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization.
  • The composite of MACCE and its individual components of 2-5 years period of follow-up (patient reported) [ Time Frame: 2-5 Years ] [ Designated as safety issue: Yes ]
    MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization
  • Myocardial Infarction (MI) - according to Universal MI definition 2012 [ Time Frame: 1 Years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis - according to ARC definitions [ Time Frame: 1 Years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction - according to Universal MI definition 2012 [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction - according to Universal MI definition 2012 [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction - according to Universal MI definition 2012 [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction - according to Universal MI definition 2012 [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis - according to ARC definitions [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis - according to ARC definitions [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis - according to ARC definitions [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis - according to ARC definitions [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
Same as current
Composite of MACCE at 5 years follow-up compared to coronary artery bypass graft (CABG) arm of the SYNTAX I Trial [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Exploratory endpoint. MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization
Same as current
 
A Trial to Evaluate a New Strategy in the Functional Assessment of 3-vessel Disease Using the SYNTAX II Score in Patients Treated With PCI
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

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

Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
5 Years
Not Provided
Non-Probability Sample

Patients with de novo 3 vessel disease

  • Heart Diseases
  • Cardiovascular Diseases
  • 3 Vessel Coronary Artery Disease
  • Device: Coronary stent
    Other Name: SYNERGY™ EES
  • Radiation: Multi Slice Computed Tomography
    A coronary non-invasive Multi Slice Computed Tomography will be performed in patients
    Other Name: MSCT
  • Device: instantaneous wave-free ratio
    Pressure-derived, adenosine-free index on physiological assessment of stenosis severity
    Other Name: iFR
  • Device: Fractional flow reserve
    Pressure-derived index on physiological assessment of stenosis severity
    Other Name: FFR
  • Device: Intravascular Ultrasound
    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
    Other Name: IVUS
Percutaneous Coronary Intervention
All patients (single arm study) will be receiving the SYNERGY™ Everolimus eluting stent (EES)
Interventions:
  • Device: Coronary stent
  • Radiation: Multi Slice Computed Tomography
  • Device: instantaneous wave-free ratio
  • Device: Fractional flow reserve
  • Device: Intravascular Ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
December 2018
December 2015   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Eliane Lopes Dos Santos +31102402409 elopes@cardialysis.nl
Contact: Rob Schneijdenberg +31102062828 rschneijdenberg@cardialysis.nl
Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom
 
NCT02015832
ECRI-002
Yes
ECRI bv
ECRI bv
  • Boston Scientific Corporation
  • Volcano Corporation
Study Chair: Patrick Serruys, Prof. MD. Thoraxcenter, Erasmus, The Netherlands
Principal Investigator: Javier Escaned, MD Hospital San Carlos Madrid, Spain
Principal Investigator: Adrian Banning, MD John Radcliffe Hospital, Oxford, United Kingdom
Study Director: Gerrit-Anne van Es ECRI, The Netherlands
Principal Investigator: Arie-Pieter Kappetein, MD Thorax center, Erasmus, The Netherlands
Principal Investigator: David Taggart, MD John Radcliffe Hospital, Oxford. United Kingdom
Principal Investigator: Vasim Farooq, MD Manchester Royal Infirmary, United Kingdom
ECRI bv
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP