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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 September 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: October 29, 2014
Last verified: September 2014
  Purpose

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)


Condition Intervention
Heart Diseases
Cardiovascular Diseases
3 Vessel Coronary Artery Disease
Device: Coronary stent
Radiation: Multi Slice Computed Tomography
Device: instantaneous wave-free ratio
Device: Fractional flow reserve
Device: Intravascular Ultrasound

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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

Resource links provided by NLM:


Further study details as provided by ECRI bv:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 450
Study Start Date: December 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Percutaneous Coronary Intervention
All patients (single arm study) will be receiving the SYNERGY™ Everolimus eluting stent (EES)
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

Detailed 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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with de novo 3 vessel disease

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015832

Contacts
Contact: Eliane Lopes Dos Santos +31102402409 elopes@cardialysis.nl
Contact: Rob Schneijdenberg +31102062828 rschneijdenberg@cardialysis.nl

Locations
Netherlands
Research Center NL002 Withdrawn
Leeuwarden, Friesland, Netherlands
Research Center NL007 Recruiting
Amsterdam, Noord Holland, Netherlands
Contact: Research Coordinator         
Principal Investigator: local         
Research Center NL014 Recruiting
Nieuwegein, Utrecht, Netherlands
Contact: Local Investigator         
Principal Investigator: local         
Research Center NL001 Recruiting
Rotterdam, Zuid-Holland, Netherlands
Contact: Research Coordinator         
Principal Investigator: local         
Poland
Research Center PL008 Recruiting
Bielsko-Biała, Poland
Contact: Research Coordinator         
Principal Investigator: local         
Research Center PL012 Not yet recruiting
Katowice, Poland
Contact: Local Investigator         
Principal Investigator: local         
Research Center PL010 Not yet recruiting
Krakow, Poland
Contact: Research Coordinator         
Principal Investigator: local         
Research Center PL011 Not yet recruiting
Krakow, Poland
Contact: Research Coordinator         
Principal Investigator: local         
Research Center PL004 Recruiting
Poznan, Poland
Contact: Research Coordinator         
Principal Investigator: local         
Spain
Research Center ES009 Recruiting
Santander, Cantabria, Spain
Contact: local Investigator         
Principal Investigator: local         
Research Center ES013 Withdrawn
Leon, Castilla y Leon, Spain
Research Center ES001 Recruiting
Barcelona, Cataluna, Spain
Contact: Research Coordinator         
Principal Investigator: local         
Research Center ES007 Recruiting
Madrid, Comunidad Autonoma de Madrid, Spain
Contact: local Investigator         
Principal Investigator: local         
Research Center ES012 Recruiting
Madrid, Comunidad Autonoma de Madrid, Spain
Contact: local Investigator         
Principal Investigator: local         
Research Center ES015 Recruiting
Madrid, Comunidad Autonoma de Madrid, Spain
Contact: Research Coordinator         
Principal Investigator: local         
Research Center ES004 Recruiting
Vigo, Galicia, Spain
Contact: Research Coordinator         
Principal Investigator: local         
Research Center ES008 Withdrawn
Murcia, Region de Murcia, Spain
Research Center ES016 Recruiting
Salamanca, Spain
Contact: local Investigator         
Principal Investigator: local         
Switzerland
Research Center CH004 Recruiting
Lausanne, Switzerland
Contact: Research Coordinator         
Principal Investigator: local         
United Kingdom
Research Center GB014 Recruiting
Belfast, County Antrim, United Kingdom
Contact: Research Coordinator         
Principal Investigator: local         
Research Center GB019 Recruiting
Oxford, Oxfordshire, United Kingdom
Contact: Research Coordinator         
Principal Investigator: local         
Research Center GB020 Recruiting
Cambridge, United Kingdom
Contact: Research Coordinator         
Principal Investigator: local         
Research Center GB015 Recruiting
Edinburgh, United Kingdom
Contact: Research Coordinator         
Principal Investigator: local         
Research Center GB001 Recruiting
Liverpool, United Kingdom
Contact: Local Investigator         
Principal Investigator: local         
Research Center GB016 Withdrawn
London, United Kingdom
Research Center GB017 Recruiting
London, United Kingdom
Contact: Research Coordinator         
Principal Investigator: local         
Research Center GB018 Withdrawn
London, United Kingdom
Research Center GB006 Recruiting
Manchester, United Kingdom
Contact: Research Coordinator         
Principal Investigator: local         
Research Center GB013 Recruiting
Newcastle upon Tyne, United Kingdom
Contact: Research Coordinator         
Principal Investigator: local         
Sponsors and Collaborators
ECRI bv
Boston Scientific Corporation
Volcano Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: ECRI bv
ClinicalTrials.gov Identifier: NCT02015832     History of Changes
Other Study ID Numbers: ECRI-002
Study First Received: December 13, 2013
Last Updated: October 29, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee

Keywords provided by ECRI bv:
SYNTAX II Score
Pressure wires
instantaneous wave-free ratio
fractional flow reserve
intravascular ultrasound
Drug eluting stents
Stents
Angioplasty
multi slice computed tomography

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014