NCT02015832

Brief 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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
4 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 16, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

3.1 years

First QC Date

December 13, 2013

Results QC Date

November 15, 2021

Last Update Submit

July 12, 2022

Conditions

Heart DiseasesCardiovascular Diseases3 Vessel Coronary Artery Disease

Keywords

SYNTAX II ScorePressure wiresinstantaneous wave-free ratiofractional flow reserveintravascular ultrasoundDrug eluting stentsStentsAngioplastymulti slice computed tomography

Outcome Measures

Primary Outcomes (1)

  • Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization

    1 year

Secondary Outcomes (7)

  • Number of Participants With All-cause Death, Stroke, or Myocardial Infarction

    1 Year

  • Number of Participants With All-cause Death

    1 Year

  • Number of Participants With Stroke

    1 Year

  • Number of Participants With Myocardial Infarction

    1 year

  • Number of Participants With Revascularization

    1 Years

  • +2 more secondary outcomes

Study Arms (1)

Percutaneous Coronary Intervention

All patients (single arm study) will be receiving the SYNERGY™ Everolimus eluting stent (EES)

Device: Coronary stentRadiation: Multi Slice Computed TomographyDevice: instantaneous wave-free ratioDevice: Fractional flow reserveDevice: Intravascular Ultrasound

Interventions

Coronary stentDEVICE
Also known as: SYNERGY™ EES
Percutaneous Coronary Intervention
Multi Slice Computed TomographyRADIATION

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

Also known as: MSCT
Percutaneous Coronary Intervention
instantaneous wave-free ratioDEVICE

Pressure-derived, adenosine-free index on physiological assessment of stenosis severity

Also known as: iFR
Percutaneous Coronary Intervention
Fractional flow reserveDEVICE

Pressure-derived index on physiological assessment of stenosis severity

Also known as: FFR
Percutaneous Coronary Intervention
Intravascular UltrasoundDEVICE

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

Also known as: IVUS
Percutaneous Coronary Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with de novo 3 vessel disease

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Research Center NL007

Amsterdam, North Holland, Netherlands

Location

Research Center NL001

Rotterdam, South Holland, Netherlands

Location

Research Center PL008

Bielsko-Biala, Poland

Location

Research Center PL012

Katowice, Poland

Location

Research Center PL010

Krakow, Poland

Location

Research Center PL004

Poznan, Poland

Location

Research Center ES009

Santander, Cantabria, Spain

Location

Research Center ES001

Barcelona, Catalonia, Spain

Location

Research Center ES004

Vigo, Galicia, Spain

Location

Research Center ES007

Madrid, Madrid, Spain

Location

Research Center ES012

Madrid, Madrid, Spain

Location

Research Center ES015

Madrid, Madrid, Spain

Location

Research Center ES016

Salamanca, Spain

Location

Research Center GB014

Belfast, County Antrim, United Kingdom

Location

Research Center GB019

Oxford, Oxfordshire, United Kingdom

Location

Research Center GB005

Brighton, United Kingdom

Location

Research Center GB020

Cambridge, United Kingdom

Location

Research Center GB015

Edinburgh, United Kingdom

Location

Research Center GB001

Liverpool, United Kingdom

Location

Research Center GB017

London, United Kingdom

Location

Research Center GB006

Manchester, United Kingdom

Location

Research Center GB013

Newcastle upon Tyne, United Kingdom

Location

Related Publications (4)

  • Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20.

    PMID: 34666500DERIVED

  • Collet C, Miyazaki Y, Ryan N, Asano T, Tenekecioglu E, Sonck J, Andreini D, Sabate M, Brugaletta S, Stables RH, Bartorelli A, de Winter RJ, Katagiri Y, Chichareon P, De Maria GL, Suwannasom P, Cavalcante R, Jonker H, Morel MA, Cosyns B, Kappetein AP, Taggart DT, Farooq V, Escaned J, Banning A, Onuma Y, Serruys PW. Fractional Flow Reserve Derived From Computed Tomographic Angiography in Patients With Multivessel CAD. J Am Coll Cardiol. 2018 Jun 19;71(24):2756-2769. doi: 10.1016/j.jacc.2018.02.053. Epub 2018 May 22.

    PMID: 29802016DERIVED

  • Escaned J, Collet C, Ryan N, De Maria GL, Walsh S, Sabate M, Davies J, Lesiak M, Moreno R, Cruz-Gonzalez I, Hoole SP, Ej West N, Piek JJ, Zaman A, Fath-Ordoubadi F, Stables RH, Appleby C, van Mieghem N, van Geuns RJ, Uren N, Zueco J, Buszman P, Iniguez A, Goicolea J, Hildick-Smith D, Ochala A, Dudek D, Hanratty C, Cavalcante R, Kappetein AP, Taggart DP, van Es GA, Morel MA, de Vries T, Onuma Y, Farooq V, Serruys PW, Banning AP. Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study. Eur Heart J. 2017 Nov 7;38(42):3124-3134. doi: 10.1093/eurheartj/ehx512.

    PMID: 29020367DERIVED

  • Farooq V, Serruys PW. Bypass Grafting Versus Percutaneous Intervention-Which Is Better in Multivessel Coronary Disease: Lessons From SYNTAX and Beyond. Prog Cardiovasc Dis. 2015 Nov-Dec;58(3):316-34. doi: 10.1016/j.pcad.2015.10.002. Epub 2015 Oct 31.

    PMID: 26529569DERIVED

MeSH Terms

Conditions

Heart DiseasesCardiovascular Diseases

Interventions

Ultrasonography, Interventional

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Ernest Spitzer
Organization
European Cardiovascular Research Institute
E.Spitzer@ECRI-Trials.com
+31102062828

Study Officials

  • Ernest Spitzer, MD

    European Cardiovascular Research Institute

    STUDY DIRECTOR

  • Javier Escaned, MD

    Hospital San Carlos Madrid, Spain

    PRINCIPAL INVESTIGATOR

  • Adrian Banning, MD

    John Radcliffe Hospital, Oxford, United Kingdom

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2013

First Posted

December 19, 2013

Study Start

February 6, 2014

Primary Completion

March 28, 2017

Study Completion

February 4, 2021

Last Updated

July 21, 2022

Results First Posted

June 16, 2022

Record last verified: 2022-07

Locations

GB(9)PL(4)ES(7)NL(2)