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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 2 Stents | Experimental | Patients who are going to receive 2 stents in both vessels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 Stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Death, Myocardial infarction and Target Lesion Revascularisation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Death | 1 year | |
| Myocardial Infarction | 1 year | |
| Target Lesion Revascularization |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time. | up to 18 months | |
| Technical success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time. |
Inclusion Criteria:
Patients must meet ALL of the inclusion criteria:
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
Patient ≥18 years old
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Tiago | Contact | +33176739258 | ptiago@cerc-europe.org |
| Name | Affiliation | Role |
|---|---|---|
| David Hildick-Smith, Dr | Brighton and Sussex University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Active, not recruiting | Aarhus | 8200 | Denmark | ||
| Rigshospitalet Copenhagen University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40959874 | Derived | 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. | |
| 39907022 |
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|
| 2 Stents | Device | 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. |
|
| 1 year |
| Angina status | 1 year |
| Stent thrombosis | 1 year |
| Death | 3 years |
| Myocardial Infarction | 3 years |
| Target Lesion Revascularization | 3 years |
| up to 18 months |
| Number of procedural and in-hospital Major adverse Cardiac Events (MACE) | up to 18 months |
| Procedure duration | intraoperative |
| Fluoroscopy by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time | up to 18 months |
| X-ray dose | up to 18 months |
| Economic evaluation by assessing all procedural costs for each stenting strategy | up to 18 months |
| Active, not recruiting |
| Copenhagen |
| 2100 |
| Denmark |
| Clinique de Fontaine | Not yet recruiting | Fontaine-lès-Dijon | 21121 | France |
|
| HCL CHU Luis Pradel | Not yet recruiting | Lyon | 69500 | France |
|
| Hopital Jacques Cartier | Not yet recruiting | Massy | 91300 | France |
|
| Clinique Saint Hilaire | Not yet recruiting | Rouen | 76000 | France |
|
| Clinique Pasteur | Not yet recruiting | Toulouse | 31076 | France |
|
| CHU Rangueil | Not yet recruiting | Toulouse | 31403 | France |
|
| Herzzentrum Bad Krozingen | Not yet recruiting | Bad Krozingen | 79189 | Germany |
|
| Elisabeth Krankenhaus Essen | Recruiting | Essen | 45138 | Germany |
|
| University of Catania - Ferrarotto Hospital | Not yet recruiting | Catania | 95124 | Italy |
|
| Ospedale San Raffaele | Not yet recruiting | Milan | 20132 | Italy |
|
| Universita Cattolica del Sacre Cuore | Not yet recruiting | Roma | 00168 | Italy |
|
| Pauls Stradins Clinical University Hospital | Active, not recruiting | Riga | 1002 | Latvia |
| Clinical Center of Serbia | Active, not recruiting | Belgrade | 11000 | Serbia |
| Hospital del Mar | Recruiting | Barcelona | 08003 | Spain |
|
| Hospital Clinic de Barcelona | Active, not recruiting | Barcelona | 08006 | Spain |
| Hospital Sant Pau i Sant Creu | Active, not recruiting | Barcelona | 08025 | Spain |
| Hospital de la Reina Sofia | Not yet recruiting | Córdoba | 14004 | Spain |
|
| Belfast City Hospital | Not yet recruiting | Belfast | BT97AB | United Kingdom |
|
| Royal Sussex County Hospital | Recruiting | Brighton | United Kingdom |
|
| St Thomas Hospital | Not yet recruiting | London | SE1 7EH | United Kingdom |
|
| Freeman Hospital | Not yet recruiting | Newcastle upon Tyne | NE7 7DN | United Kingdom |
|
| John Radcliffe Hospital | Not yet recruiting | Oxford | OX3 9DU | United Kingdom |
|
| Derived |
| 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. |
| 36709485 | Derived | 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. |
| 34002215 | Derived | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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