Trial Evaluating New Strategy in the Functional Assessment of 3-vessel Disease Using SYNTAXII Score in Patients With PCI

NCT ID: NCT02015832

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 454 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-06
• Study Completion Date: 2021-02-04

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)

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

Conditions

Heart Diseases; Cardiovascular Diseases; 3 Vessel Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Percutaneous Coronary Intervention

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

Coronary stent

Intervention Type: DEVICE

Multi Slice Computed Tomography

Intervention Type: RADIATION

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

instantaneous wave-free ratio

Intervention Type: DEVICE

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

Fractional flow reserve

Intervention Type: DEVICE

Pressure-derived index on physiological assessment of stenosis severity

Intravascular Ultrasound

Intervention Type: DEVICE

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

Interventions

Coronary stent

Intervention Type: DEVICE

Multi Slice Computed Tomography

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

Intervention Type: RADIATION

instantaneous wave-free ratio

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

Intervention Type: DEVICE

Fractional flow reserve

Pressure-derived index on physiological assessment of stenosis severity

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

SYNERGY™ EES; MSCT; iFR; FFR; IVUS

Eligibility 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

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Volcano Corporation

INDUSTRY

Sponsor Role: collaborator

ECRI bv

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ernest Spitzer, MD

Role: STUDY_DIRECTOR

European Cardiovascular Research Institute

Javier Escaned, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Carlos Madrid, Spain

Adrian Banning, MD

Role: PRINCIPAL_INVESTIGATOR

John Radcliffe Hospital, Oxford, United Kingdom

Locations

Research Center NL007

Amsterdam, North Holland, Netherlands

Research Center NL001

Rotterdam, South Holland, Netherlands

Research Center PL008

Bielsko-Biala, , Poland

Research Center PL012

Katowice, , Poland

Research Center PL010

Krakow, , Poland

Research Center PL004

Poznan, , Poland

Research Center ES009

Santander, Cantabria, Spain

Research Center ES001

Barcelona, Catalonia, Spain

Research Center ES004

Vigo, Galicia, Spain

Research Center ES007

Madrid, Madrid, Spain

Research Center ES012

Madrid, Madrid, Spain

Research Center ES015

Madrid, Madrid, Spain

Research Center ES016

Salamanca, , Spain

Research Center GB014

Belfast, County Antrim, United Kingdom

Research Center GB019

Oxford, Oxfordshire, United Kingdom

Research Center GB005

Brighton, , United Kingdom

Research Center GB020

Cambridge, , United Kingdom

Research Center GB015

Edinburgh, , United Kingdom

Research Center GB001

Liverpool, , United Kingdom

Research Center GB017

London, , United Kingdom

Research Center GB006

Manchester, , United Kingdom

Research Center GB013

Newcastle upon Tyne, , United Kingdom

Countries

Netherlands; Poland; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34666500 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29802016 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29020367 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26529569 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ECRI-002

Identifier Type: -

Identifier Source: org_study_id