Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
450 participants
INTERVENTIONAL
2016-02-29
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1 Stent
Patients who are going to receive 1 stent in the main vessel and the side vessel will be treated with kissing ballon inflation
1 Stent
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 Stents
Patients who are going to receive 2 stents in both vessels
2 Stents
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.
Interventions
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1 Stent
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 Stents
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.
Eligibility Criteria
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Inclusion Criteria
* Ischaemic symptoms, or
* Positive non-invasive imaging for ischaemia, or
* Positive FFR, or
* LMS IVUS MLA \<6mm2
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
European Cardiovascular Research Center
NETWORK
Responsible Party
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Principal Investigators
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David Hildick-Smith, Dr
Role: PRINCIPAL_INVESTIGATOR
Brighton and Sussex University Hospitals NHS Trust
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet Copenhagen University Hospital
Copenhagen, , Denmark
Clinique de Fontaine
Fontaine-lès-Dijon, , France
HCL CHU Luis Pradel
Lyon, , France
Hopital Jacques Cartier
Massy, , France
Clinique Saint Hilaire
Rouen, , France
Clinique Pasteur
Toulouse, , France
CHU Rangueil
Toulouse, , France
Herzzentrum Bad Krozingen
Bad Krozingen, , Germany
Elisabeth Krankenhaus Essen
Essen, , Germany
University of Catania - Ferrarotto Hospital
Catania, , Italy
Ospedale San Raffaele
Milan, , Italy
Universita Cattolica del Sacre Cuore
Roma, , Italy
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Clinical Center of Serbia
Belgrade, , Serbia
Hospital del Mar
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Sant Pau i Sant Creu
Barcelona, , Spain
Hospital de la Reina Sofia
Córdoba, , Spain
Belfast City Hospital
Belfast, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
St Thomas Hospital
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Edda Calabro
Role: primary
Severine Roger
Role: primary
Françoise Hupel
Role: primary
Frédéric Petit
Role: primary
Vanessa Reuter
Role: primary
Laura Basile
Role: primary
Vega Rusconi
Role: primary
Paula Cabrero Cereto
Role: primary
Eva Cebrian
Role: primary
Nicola Skipper
Role: primary
Lucy Clack
Role: primary
Bijal Patel
Role: primary
Ellie Corps
Role: primary
References
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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, Chieff 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 Sep 17:e015546. doi: 10.1161/CIRCINTERVENTIONS.125.015546. Online ahead of print.
Arunothayaraj 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.
Arunothayaraj 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.
Hildick-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.
Other Identifiers
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MED-03
Identifier Type: -
Identifier Source: org_study_id
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