Percutaneous Transluminal Coronary AngioplastyEBC MAINNCT02497014
The European Bifurcation Club Left Main Study
A study testing 1 Stent and 2 Stents in people with Percutaneous Transluminal Coronary Angioplasty and Coronary Artery Disease, run by European Cardiovascular Research Center at 24 sites in 8 countries.
Trial summary
The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Disease
- What is being tested?
- 1 Stent and 2 Stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 24 sitesin 8 countries
- Study dates
- Feb 2016to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet ALL of the inclusion criteria:
- Bifurcation distal left main stem stenosis >50% and
- Ischaemic symptoms, or
- Positive non-invasive imaging for ischaemia, or
- Positive FFR, or
- LMS IVUS MLA <6mm2
Show all 11Show fewer
- Left main diameter ≤5.75mm
- True bifurcation lesion type 1,1,1 or 0,1,1
- LAD and Cx diameter both >2.75mm
- Unprotected left main
- Patient ≥18 years old
Who cannot join
- STEMI <72 hours preceding
- Cardiogenic shock
- Chronic total occlusion of either vessel
- >2 other coronary lesions planned for treatment
- SYNTAX score for planned lesions to be treated >32
- LMS trifurcation if all vessels are ≥2.75mm diameter
Show all 13Show fewer
- Either bifurcation vessel not suitable for stenting
- Platelet count ≤50 x 10^9/mm3
- Left ventricular ejection fraction ≤20%
- Patient life expectancy less than 12 months
- Participation in another investigational drug or device study
- Patient unable to give informed consent
- Women of child-bearing potential or lactating
Trial locations and contacts
24 sites in 8 countries.
24 sites in 8 countries
France6 sites, 6 recruiting
- Not yet recruiting
Clinique de Fontaine
Fontaine-lès-Dijon, 21121
Edda Calabro
Philippe Brunel
- Not yet recruiting
HCL CHU Luis Pradel
Lyon, 69500
Gérard Finet
- Not yet recruiting
Hopital Jacques Cartier
Massy, 91300
Severine Roger
Thomas Hovasse, Dr
- Not yet recruiting
Clinique Saint Hilaire
Rouen, 76000
Françoise Hupel
René Koning
- Not yet recruiting
Clinique Pasteur
Toulouse, 31076
Frédéric Petit
Jean Fajadet
- Not yet recruiting
CHU Rangueil
Toulouse, 31403
Jacqueline Cahuzac, 0033 5 61 32 33 45, Cahuzac.j@chu-toulouse.fr
Ludovic Lacassagne, 0033 5 61 32 33 45, Ludo.lacassagne@gmail.com
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
Belfast City Hospital
Belfast, BT97AB
Mark Spence
- Recruiting
Royal Sussex County Hospital
Brighton
Nicola Skipper
David Hildick-Smith, David
- Not yet recruiting
St Thomas Hospital
London, SE1 7EH
Lucy Clack
Simon Redwood, Dr
- Not yet recruiting
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Bijal Patel
Mohaned Egred, Dr
- Not yet recruiting
John Radcliffe Hospital
Oxford, OX3 9DU
Ellie Corps
Adrian Banning
Spain4 sites, 2 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
Paula Cabrero Cereto
Beatriz Vaquerizo, Dr
- Active, not recruiting
Hospital Clinic de Barcelona
Barcelona, 08006
- Active, not recruiting
Hospital Sant Pau i Sant Creu
Barcelona, 08025
- Not yet recruiting
Hospital de la Reina Sofia
Córdoba, 14004
Eva Cebrian
Manuel Pan Alvarez Ossorio
Italy3 sites, 3 recruiting
- Not yet recruiting
University of Catania - Ferrarotto Hospital
Catania, 95124
Laura Basile
Corrado Tamburino
- Not yet recruiting
Ospedale San Raffaele
Milan, 20132
Vega Rusconi
Alaide Chieffo
- Not yet recruiting
Universita Cattolica del Sacre Cuore
Roma, 00168
Francesco Burzotta
Denmark2 sites
- Active, not recruiting
Aarhus University Hospital
Aarhus, 8200
- Active, not recruiting
Rigshospitalet Copenhagen University Hospital
Copenhagen, 2100
Germany2 sites, 2 recruiting
- Not yet recruiting
Herzzentrum Bad Krozingen
Bad Krozingen, 79189
Gudrun Dietsche, +49 76 33 402 5213, Gudrun.Dietsche@herzzentrum.de
Johanna Korb, +49 7633 402 5211, ohanna.korb@herzzentrum.de
- Recruiting
Elisabeth Krankenhaus Essen
Essen, 45138
Vanessa Reuter
Christoph Naber
Latvia1 site
- Active, not recruiting
Pauls Stradins Clinical University Hospital
Riga, 1002
About this study
Official title: The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions
The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.
- Being tested
- 1 Stent, 2 Stents
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 StentDevice
Stenting of main vessel should be undertaken with a wire jailed in the side vessel to preserve side vessel flow and access. Stent diameter should be chosen according to diameter of the main vessel immediately distal to the bifurcation. Distal left main should be dilated with a short non-compliant balloon. Side vessel should be rewired and a kissing balloon inflation should be undertaken. Balloon sizes should be according to the diameter of the main and side vessel with individual high pressure inflation followed by a final lower pressure kiss dilatation. Proximal stented portion in the left main coronary artery should be dilated to full expansion using either low pressure dilatation of the kissing balloon pair or a separate individual balloon. It is preferred that non-compliant balloons should be used to limit overstretching of vessels. In case of specific situations described in the protocol the operator may choose to implant a side vessel stent, using same process as described above.
2 StentsDevice
Coronary guide wires should be passed to LAD and Cx/intermediate arteries respectively. One should be designated the main vessel and one should be designated the side vessel. The planned dual stent technique is at the discretion of the operator but should be one of culotte, minicrush, T or TAP. If a crush procedure is chosen, it should ideally be of the DK variety. Stent diameter should be chosen according to the diameter of the vessel immediately distal to the bifurcation. Wire jail, POT, non-compliant balloons, high pressure individual "ostial" dilatations and final dilatation of the stented proximal left main should be used in accordance with the advice of the EBC. Further treatment to proximal or distal aspects of the main vessel or side vessel can be continued at the discretion of the operator. At any stage, proximal or distal dissections may be treated as required with further stent implantations. At any stage, post-dilatations may be undertaken to optimise stent expansion.
| Study group | Role | What they receive |
|---|---|---|
| 1 Stent | Experimental | Patients who are going to receive 1 stent in the main vessel and the side vessel will be treated with kissing ballon inflation Receives: Device: 1 Stent |
| 2 Stents | Experimental | Patients who are going to receive 2 stents in both vessels Receives: Device: 2 Stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Death, Myocardial infarction and Target Lesion Revascularisation
Measured: 1 year
Secondary outcomes (8)
Death
Measured: 1 year
Myocardial Infarction
Measured: 1 year
Target Lesion Revascularization
Measured: 1 year
Angina status
Measured: 1 year
Stent thrombosis
Measured: 1 year
Death
Measured: 3 years
Myocardial Infarction
Measured: 3 years
Target Lesion Revascularization
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Transluminal Coronary AngioplastyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Cardiovascular Research Center
- Sponsor type
- Research network
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- David Hildick-Smith, Dr, Principal investigator, Brighton and Sussex University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497014
- Sponsor's protocol ID
- MED-03
- Acronym
- EBC MAIN
- Status last verified
- Mar 2016
- First submitted
- 1 Jul 2015
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Maznyczka A, Arunothayaraj S, Banning AP, Schmitz T, Wlodarczak A, Silvestri M, Egred M, Koning R, Spence MS, Morice MC, Lefevre T, Ferenc M, Cockburn J, Erglis A, Brunel P, Burzotta F, Kretov E, Hovasse T, Pan M, Clesham G, Chieffo A, Mylotte D, Lindsay M, Christiansen EH, Bouisset F, Vaquerizo B, Lassen JF, Darremont O, Louvard Y, Stankovic G, Hildick-Smith D; EBC MAIN (European Bifurcation Club Left Main Coronary Stent) Trial Investigators. Patterns of Restenosis After Left Main Bifurcation Single- or Dual-Stenting: An EBC MAIN Trial Subanalysis. Circ Cardiovasc Interv. 2025 Nov;18(11):e015546. doi: 10.1161/CIRCINTERVENTIONS.125.015546. Epub 2025 Sep 17.
PubMed 40959874Arunothayaraj S, Egred M, Banning AP, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefevre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y, Hildick-Smith D. Stepwise Provisional Versus Systematic Dual-Stent Strategies for Treatment of True Left Main Coronary Bifurcation Lesions. Circulation. 2025 Mar 4;151(9):612-622. doi: 10.1161/CIRCULATIONAHA.124.071153. Epub 2025 Feb 5.
PubMed 39907022Arunothayaraj S, Lassen JF, Clesham GJ, Spence MS, Koning R, Banning AP, Lindsay M, Christiansen EH, Egred M, Cockburn J, Mylotte D, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Silvestri M, Erglis A, Kretov E, Chieffo A, Lefevre T, Burzotta F, Darremont O, Stankovic G, Morice MC, Louvard Y, Hildick-Smith D. Impact of technique on bifurcation stent outcomes in the European Bifurcation Club Left Main Coronary Trial. Catheter Cardiovasc Interv. 2023 Feb;101(3):553-562. doi: 10.1002/ccd.30575. Epub 2023 Jan 29.
PubMed 36709485Hildick-Smith D, Egred M, Banning A, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefevre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN). Eur Heart J. 2021 Oct 1;42(37):3829-3839. doi: 10.1093/eurheartj/ehab283.
PubMed 34002215
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT02497014
- Acronym / sponsor ID
- EBC MAIN / MED-03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- European Cardiovascular Research CenterResearch network
- Collaborators
- Medtronic
- Study start
- Feb 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Stent | Experimental | Device: 1 StentPatients who are going to receive 1 stent in the main vessel and the side vessel will be treated with kissing ballon inflation |
| 2 Stents | Experimental | Device: 2 StentsPatients who are going to receive 2 stents in both vessels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Bifurcation distal left main stem stenosis >50% and
- Left main diameter ≤5.75mm
- True bifurcation lesion type 1,1,1 or 0,1,1
- LAD and Cx diameter both >2.75mm
- Unprotected left main
Key exclusion criteria (13 listed)
- STEMI <72 hours preceding
- Cardiogenic shock
- Chronic total occlusion of either vessel
- >2 other coronary lesions planned for treatment
- SYNTAX score for planned lesions to be treated >32
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 |
|---|---|---|
| 1 StentStenting of main vessel should be undertaken with a wire jailed in the side vessel to preserve side vessel flow and access. Stent diameter should be chosen according to diameter of the main vessel immediately distal to the bifurcation. Distal left main should be dilated with a short non-compliant balloon. Side vessel should be rewired and a kissing balloon inflation should be undertaken. Balloon sizes should be according to the diameter of the main and side vessel with individual high pressure inflation followed by a final lower pressure kiss dilatation. Proximal stented portion in the left main coronary artery should be dilated to full expansion using either low pressure dilatation of the kissing balloon pair or a separate individual balloon. It is preferred that non-compliant balloons should be used to limit overstretching of vessels. In case of specific situations described in the protocol the operator may choose to implant a side vessel stent, using same process as described above. | Device | 1 Stent |
| 2 StentsCoronary guide wires should be passed to LAD and Cx/intermediate arteries respectively. One should be designated the main vessel and one should be designated the side vessel. The planned dual stent technique is at the discretion of the operator but should be one of culotte, minicrush, T or TAP. If a crush procedure is chosen, it should ideally be of the DK variety. Stent diameter should be chosen according to the diameter of the vessel immediately distal to the bifurcation. Wire jail, POT, non-compliant balloons, high pressure individual "ostial" dilatations and final dilatation of the stented proximal left main should be used in accordance with the advice of the EBC. Further treatment to proximal or distal aspects of the main vessel or side vessel can be continued at the discretion of the operator. At any stage, proximal or distal dissections may be treated as required with further stent implantations. At any stage, post-dilatations may be undertaken to optimise stent expansion. | Device | 2 Stents |
Primary outcome
Composite of Death, Myocardial infarction and Target Lesion Revascularisation
Time frame: 1 year
8 secondary outcomes
Death
Time frame: 1 year
Myocardial Infarction
Time frame: 1 year
Target Lesion Revascularization
Time frame: 1 year
Angina status
Time frame: 1 year
Stent thrombosis
Time frame: 1 year
Death
Time frame: 3 years
Myocardial Infarction
Time frame: 3 years
Target Lesion Revascularization
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Derived from this study: PubMed 40959874Maznyczka A, Arunothayaraj S, Banning AP, Schmitz T, Wlodarczak A, Silvestri M, Egred M, Koning R, Spence MS, Morice MC, Lefevre T, Ferenc M, Cockburn J, Erglis A, Brunel P, Burzotta F, Kretov E, Hovasse T, Pan M, Clesham G, Chieffo A, Mylotte D, Lindsay M, Christiansen EH, Bouisset F, Vaquerizo B, Lassen JF, Darremont O, Louvard Y, Stankovic G, Hildick-Smith D; EBC MAIN (European Bifurcation Club Left Main Coronary Stent) Trial Investigators. Patterns of Restenosis After Left Main Bifurcation Single- or Dual-Stenting: An EBC MAIN Trial Subanalysis. Circ Cardiovasc Interv. 2025 Nov;18(11):e015546. doi: 10.1161/CIRCINTERVENTIONS.125.015546. Epub 2025 Sep 17.
- Derived from this study: PubMed 39907022Arunothayaraj S, Egred M, Banning AP, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefevre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y, Hildick-Smith D. Stepwise Provisional Versus Systematic Dual-Stent Strategies for Treatment of True Left Main Coronary Bifurcation Lesions. Circulation. 2025 Mar 4;151(9):612-622. doi: 10.1161/CIRCULATIONAHA.124.071153. Epub 2025 Feb 5.
- Derived from this study: PubMed 36709485Arunothayaraj S, Lassen JF, Clesham GJ, Spence MS, Koning R, Banning AP, Lindsay M, Christiansen EH, Egred M, Cockburn J, Mylotte D, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Silvestri M, Erglis A, Kretov E, Chieffo A, Lefevre T, Burzotta F, Darremont O, Stankovic G, Morice MC, Louvard Y, Hildick-Smith D. Impact of technique on bifurcation stent outcomes in the European Bifurcation Club Left Main Coronary Trial. Catheter Cardiovasc Interv. 2023 Feb;101(3):553-562. doi: 10.1002/ccd.30575. Epub 2023 Jan 29.
- Derived from this study: PubMed 34002215Hildick-Smith D, Egred M, Banning A, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefevre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN). Eur Heart J. 2021 Oct 1;42(37):3829-3839. doi: 10.1093/eurheartj/ehab283.
- Individual participant dataSharing planned: No
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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.
David Hildick-Smith, Dr principal investigator
Brighton and Sussex University Hospitals NHS Trust
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 Stent and 2 Stents in people with Percutaneous Transluminal Coronary Angioplasty and Coronary Artery Disease, run by European Cardiovascular Research Center at 24 sites in 8 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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, United Kingdom, Spain, Italy, Denmark and 3 more countries. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Tiago (+33176739258, ptiago@cerc-europe.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Death, Myocardial infarction and Target Lesion Revascularisation (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 NCT02497014, 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 8 Mar 2016.