Heart DiseasesNCT02015832
Trial Evaluating New Strategy in the Functional Assessment of 3-vessel Disease Using SYNTAXII Score in Patients With PCI
An observational study of Heart Diseases and Cardiovascular Diseases, run by ECRI bv at 22 sites in 4 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Diseases, Cardiovascular Diseases, 3 Vessel Coronary Artery Disease
- What is being tested?
- Coronary stent, Multi Slice Computed Tomography and instantaneous wave-free ratio
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 454 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 6 Feb 2014to 4 Feb 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with de novo 3 vessel disease
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United Kingdom9 sites
Research Center GB014
Belfast, County Antrim
Research Center GB005
Brighton
Research Center GB020
Cambridge
Research Center GB015
Edinburgh
Research Center GB001
Liverpool
Research Center GB017
London
Research Center GB006
Manchester
Research Center GB013
Newcastle upon Tyne
Research Center GB019
Oxford, Oxfordshire
Spain7 sites
Research Center ES001
Barcelona, Catalonia
Research Center ES007
Madrid, Madrid
Research Center ES012
Madrid, Madrid
Research Center ES015
Madrid, Madrid
Research Center ES016
Salamanca
Research Center ES009
Santander, Cantabria
Research Center ES004
Vigo, Galicia
Poland4 sites
Research Center PL008
Bielsko-Biala
Research Center PL012
Katowice
Research Center PL010
Krakow
Research Center PL004
Poznan
Netherlands2 sites
Research Center NL007
Amsterdam, North Holland
Research Center NL001
Rotterdam, South Holland
About this study
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
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)
Read the 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
- Being tested
- Coronary stent, Multi Slice Computed Tomography, instantaneous wave-free ratio, Fractional flow reserve, Intravascular Ultrasound
- Keywords
- SYNTAX II Score, Pressure wires, instantaneous wave-free ratio, fractional flow reserve, intravascular ultrasound, Drug eluting stents, Stents, Angioplasty, multi slice computed tomography
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary stentDevice
Also called SYNERGY™ EES
Multi Slice Computed TomographyRadiation
Also called MSCT
A coronary non-invasive Multi Slice Computed Tomography will be performed in patients
instantaneous wave-free ratioDevice
Also called iFR
Pressure-derived, adenosine-free index on physiological assessment of stenosis severity
Fractional flow reserveDevice
Also called FFR
Pressure-derived index on physiological assessment of stenosis severity
Intravascular UltrasoundDevice
Also called IVUS
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
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Coronary Intervention | All patients (single arm study) will be receiving the SYNERGY™ Everolimus eluting stent (EES) Receives: Device: Coronary stent; Radiation: Multi Slice Computed Tomography; Device: instantaneous wave-free ratio; Device: Fractional flow reserve; Device: Intravascular Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (7)
Number of Participants With All-cause Death, Stroke, or Myocardial Infarction
Safety endpoint
Measured: 1 Year
Number of Participants With All-cause Death
All-cause death
Measured: 1 Year
Number of Participants With Stroke
Stroke
Measured: 1 Year
Number of Participants With Myocardial Infarction
Any myocardial infarction
Measured: 1 year
Number of Participants With Revascularization
Any coronary revascularization
Measured: 1 Years
Number of Participants With Definite Stent Thrombosis
Stent Thrombosis - according to ARC definitions. Definite ST can be confirmed with 1) angiography (the presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest; New ischemic ECG changes that suggest acute ischemia; Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous MI); Non-occlusive thrombus or Occlusive thrombus; or 2) Pathological confirmation (evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy).
Measured: 1 Year
Number of Participants With Probable Stent Thrombosis
Stent Thrombosis - according to ARC definitions. Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: 1) Any unexplained death within the first 30 days; 2) Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study start6 Feb 2014
- Primary completion28 Mar 2017
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 454 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- ECRI bv
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, Volcano Corporation
- Responsible party
- Sponsor
- Investigators
- Ernest Spitzer, MD, Study director, European Cardiovascular Research InstituteJavier Escaned, MD, Principal investigator, Hospital San Carlos Madrid, SpainAdrian Banning, MD, Principal investigator, John Radcliffe Hospital, Oxford, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015832
- Sponsor's protocol ID
- ECRI-002
- Status last verified
- Jul 2022
- First submitted
- 13 Dec 2013
- Last updated
- 21 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34666500Collet 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.
PubMed 29802016Escaned 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.
PubMed 29020367Farooq 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.
PubMed 26529569
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02015832
- Acronym / sponsor ID
- ECRI-002
- Keywords
- SYNTAX II Score, Pressure wires, instantaneous wave-free ratio, fractional flow reserve, intravascular ultrasound, Drug eluting stents, Stents, Angioplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- ECRI bvIndustry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, Volcano Corporation
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 16 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Coronary Intervention | – | Device: Coronary stent, Radiation: Multi Slice Computed Tomography, Device: instantaneous wave-free ratio, Device: Fractional flow reserve, Device: Intravascular UltrasoundAll patients (single arm study) will be receiving the SYNERGY™ Everolimus eluting stent (EES) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with de novo 3 vessel disease
Key inclusion criteria (10 listed)
- 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
- All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary stentAlso: SYNERGY™ EES | Device | Percutaneous Coronary Intervention |
| Multi Slice Computed TomographyAlso: MSCTA coronary non-invasive Multi Slice Computed Tomography will be performed in patients | Radiation | Percutaneous Coronary Intervention |
| instantaneous wave-free ratioAlso: iFRPressure-derived, adenosine-free index on physiological assessment of stenosis severity | Device | Percutaneous Coronary Intervention |
| Fractional flow reserveAlso: FFRPressure-derived index on physiological assessment of stenosis severity | Device | Percutaneous Coronary Intervention |
| Intravascular UltrasoundAlso: IVUSAllows the application of ultrasound technology to see from inside blood vessels out through the surrounding blood column, visualizing the inner wall of blood vessels | Device | Percutaneous Coronary Intervention |
Primary outcome
Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: 1 year
MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization
7 secondary outcomes
Number of Participants With All-cause Death, Stroke, or Myocardial Infarction
Time frame: 1 Year
Number of Participants With All-cause Death
Time frame: 1 Year
Number of Participants With Stroke
Time frame: 1 Year
Number of Participants With Myocardial Infarction
Time frame: 1 year
Number of Participants With Revascularization
Time frame: 1 Years
Number of Participants With Definite Stent Thrombosis
Time frame: 1 Year
Number of Participants With Probable Stent Thrombosis
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34666500Wang 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.
- Derived from this study: PubMed 29802016Collet 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.
- Derived from this study: PubMed 29020367Escaned 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.
- Derived from this study: PubMed 26529569Farooq 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest Spitzer, MD study director
European Cardiovascular Research Institute
Javier Escaned, MD principal investigator
Hospital San Carlos Madrid, Spain
Adrian Banning, MD principal investigator
John Radcliffe Hospital, Oxford, United Kingdom
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Cardiovascular Diseases, run by ECRI bv at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Spain, Poland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02015832, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.