Clinical trial NCT02015832: Trial Evaluating New Strategy in the Functional Assessment of 3-vessel Disease Using SYNTAXII Score in Patients With PCI
Official title: Single-arm Trial Evaluating 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Cardiovascular Diseases
3 Vessel Coronary Artery Disease
Keywords: SYNTAX II Score
Pressure wires
instantaneous wave-free ratio
fractional flow reserve
intravascular ultrasound
Drug eluting stents
Stents
Angioplasty
multi slice computed tomography
Lead sponsor: ECRI bv
Sponsor class: INDUSTRY
Collaborators: name: Boston Scientific Corporation
name: Volcano Corporation
First posted: 2013-12-19
Enrollment: 454
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with de novo 3 vessel disease

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

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
* 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

Primary outcomes:
measure: Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With All-cause Death, Stroke, or Myocardial Infarction
timeFrame: 1 Year
measure: Number of Participants With All-cause Death
timeFrame: 1 Year
measure: Number of Participants With Stroke
timeFrame: 1 Year
measure: Number of Participants With Myocardial Infarction
timeFrame: 1 year
measure: Number of Participants With Revascularization
timeFrame: 1 Years
measure: Number of Participants With Definite Stent Thrombosis
timeFrame: 1 Year
measure: Number of Participants With Probable Stent Thrombosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Research Center NL007
state: Noord Holland
city: Rotterdam
country: Netherlands
facility: Research Center NL001
state: Zuid-Holland
city: Bielsko-Biała
country: Poland
facility: Research Center PL008
city: Katowice
country: Poland
facility: Research Center PL012
city: Krakow
country: Poland
facility: Research Center PL010
city: Poznan
country: Poland
facility: Research Center PL004
city: Santander
country: Spain
facility: Research Center ES009
state: Cantabria
city: Barcelona
country: Spain
facility: Research Center ES001
state: Cataluna
city: Madrid
country: Spain
facility: Research Center ES007
state: Comunidad Autonoma De Madrid
city: Madrid
country: Spain
facility: Research Center ES012
state: Comunidad Autonoma De Madrid
city: Madrid
country: Spain
facility: Research Center ES015
state: Comunidad Autonoma De Madrid
city: Vigo
country: Spain
facility: Research Center ES004
state: Galicia
city: Salamanca
country: Spain
facility: Research Center ES016
city: Belfast
country: United Kingdom
facility: Research Center GB014
state: County Antrim
city: Oxford
country: United Kingdom
facility: Research Center GB019
state: Oxfordshire
city: Brighton
country: United Kingdom
facility: Research Center GB005
city: Cambridge
country: United Kingdom
facility: Research Center GB020
city: Edinburgh
country: United Kingdom
facility: Research Center GB015
city: Liverpool
country: United Kingdom
facility: Research Center GB001
city: London
country: United Kingdom
facility: Research Center GB017
city: Manchester
country: United Kingdom
facility: Research Center GB006
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Center GB013
Study officials:
affiliation: European Cardiovascular Research Institute
name: Ernest Spitzer, MD
role: STUDY_DIRECTOR
affiliation: Hospital San Carlos Madrid, Spain
name: Javier Escaned, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: John Radcliffe Hospital, Oxford, United Kingdom
name: Adrian Banning, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.