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

NCTId: NCT02015832

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

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)

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

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 21 Years N/A False

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

Interventions & Outcomes

Study Interventions & Types

Device Intervention(s)

Coronary stent
Fractional flow reserve - Pressure-derived index on physiological assessment of stenosis severity
instantaneous wave-free ratio - Pressure-derived, adenosine-free index on physiological assessment of stenosis severity
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

Radiation Intervention(s)

Multi Slice Computed Tomography - A coronary non-invasive Multi Slice Computed Tomography will be performed in patients

Study Outcomes

Primary Outcome(s)

Timeframe: 1 year
Measure: Composite of major adverse cardiac and cerebrovascular events (MACCE) rate compared to PCI arm of SYNTAX I
Description: MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization
Safety Issue? Yes

Secondary Outcome(s)

Measure: Composite of all-cause death, cerebrovascular event (stroke), documented myocardial infarction compared to the PCI arm of SYNTAX I
Timeframe: 1 Year
Safety Issue? Yes

Measure: 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
Timeframe: 1 Year
Safety Issue? No

Measure: Myocardial Infarction - according to Universal MI definition 2012
Timeframe: 5 Years
Safety Issue? Yes

Measure: Myocardial Infarction - according to Universal MI definition 2012
Timeframe: 4 Years
Safety Issue? Yes

Measure: Myocardial Infarction - according to Universal MI definition 2012
Timeframe: 3 Years
Safety Issue? Yes

Measure: Myocardial Infarction - according to Universal MI definition 2012
Timeframe: 2 Years
Safety Issue? Yes

Measure: Myocardial Infarction (MI) - according to Universal MI definition 2012
Timeframe: 1 Years
Safety Issue? Yes

Measure: Rates of individual components of MACCE at 1 year
Timeframe: 1 Year
Description: MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization.
Safety Issue? Yes

Measure: Stent Thrombosis - according to ARC definitions
Timeframe: 1 Years
Safety Issue? Yes

Measure: Stent Thrombosis - according to ARC definitions
Timeframe: 5 Years
Safety Issue? Yes

Measure: Stent Thrombosis - according to ARC definitions
Timeframe: 4 Years
Safety Issue? Yes

Measure: Stent Thrombosis - according to ARC definitions
Timeframe: 3 Years
Safety Issue? Yes

Measure: Stent Thrombosis - according to ARC definitions
Timeframe: 2 Years
Safety Issue? Yes

Measure: The composite of MACCE and its individual components of 2-5 years period of follow-up (patient reported)
Timeframe: 2-5 Years
Description: MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization
Safety Issue? Yes

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status
First 15 facilities are shown on map

Clinical Research Study Facility Locations

Recruiting

Research Center PL004
Poznan, Poland

Research Center PL008
Bielsko-Biała, Poland

Research Center NL014
Nieuwegein, Utrecht Netherlands

Research Center NL007
Amsterdam, Noord Holland Netherlands

Research Center NL001
Rotterdam, Zuid-Holland Netherlands

Research Center GB020
Cambridge, United Kingdom

Research Center GB019
Oxford, Oxfordshire United Kingdom

Research Center GB017
London, United Kingdom

Research Center GB015
Edinburgh, United Kingdom

Research Center GB014
Belfast, County Antrim United Kingdom

Research Center GB013
Newcastle upon Tyne, United Kingdom

Research Center GB006
Manchester, United Kingdom

Research Center GB001
Liverpool, United Kingdom

Research Center ES016
Salamanca, Spain

Research Center ES015
Madrid, Comunidad Autonoma de Madrid Spain

Research Center ES012
Madrid, Comunidad Autonoma de Madrid Spain

Research Center ES009
Santander, Cantabria Spain

Research Center ES007
Madrid, Comunidad Autonoma de Madrid Spain

Research Center ES004
Vigo, Galicia Spain

Research Center ES001
Barcelona, Cataluna Spain

Research Center CH004
Lausanne, Switzerland

Not yet recruiting

Research Center PL010
Krakow, Poland

Research Center PL011
Krakow, Poland

Research Center PL012
Katowice, Poland

Withdrawn

Research Center NL002
Leeuwarden, Friesland Netherlands

Research Center GB018
London, United Kingdom

Research Center GB016
London, United Kingdom

Research Center ES013
Leon, Castilla y Leon Spain

Research Center ES008
Murcia, Region de Murcia Spain

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Heart Diseases
  2. Cardiovascular Diseases
  3. 3 Vessel Coronary Artery Disease

Other Related Condition Keywords

  1. Coronary Artery Disease
  2. Myocardial Ischemia
  3. Coronary Disease

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