NCT02497014

Brief 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
8 countries

24 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

2.5 years

First QC Date

July 1, 2015

Last Update Submit

March 7, 2016

Conditions

Percutaneous Transluminal Coronary AngioplastyCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Composite of Death, Myocardial infarction and Target Lesion Revascularisation

    1 year

Secondary Outcomes (8)

  • Death

    1 year

  • Myocardial Infarction

    1 year

  • Target Lesion Revascularization

    1 year

  • Angina status

    1 year

  • Stent thrombosis

    1 year

  • +3 more secondary outcomes

Other Outcomes (7)

  • 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.

    up to 18 months

  • Number of procedural and in-hospital Major adverse Cardiac Events (MACE)

    up to 18 months

  • +4 more other outcomes

Study Arms (2)

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

Device: 1 Stent

2 Stents

EXPERIMENTAL

Patients who are going to receive 2 stents in both vessels

Device: 2 Stents

Interventions

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.

1 Stent
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.

2 Stents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Aarhus University Hospital

Aarhus, 8200, Denmark

ACTIVE NOT RECRUITING

Rigshospitalet Copenhagen University Hospital

Copenhagen, 2100, Denmark

ACTIVE NOT RECRUITING

Clinique de Fontaine

Fontaine-lès-Dijon, 21121, France

NOT YET RECRUITING

HCL CHU Luis Pradel

Lyon, 69500, France

NOT YET RECRUITING

Hopital Jacques Cartier

Massy, 91300, France

NOT YET RECRUITING

Clinique Saint Hilaire

Rouen, 76000, France

NOT YET RECRUITING

Clinique Pasteur

Toulouse, 31076, France

NOT YET RECRUITING

CHU Rangueil

Toulouse, 31403, France

NOT YET RECRUITING

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

NOT YET RECRUITING

Elisabeth Krankenhaus Essen

Essen, 45138, Germany

RECRUITING

University of Catania - Ferrarotto Hospital

Catania, 95124, Italy

NOT YET RECRUITING

Ospedale San Raffaele

Milan, 20132, Italy

NOT YET RECRUITING

Universita Cattolica del Sacre Cuore

Roma, 00168, Italy

NOT YET RECRUITING

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

ACTIVE NOT RECRUITING

Clinical Center of Serbia

Belgrade, 11000, Serbia

ACTIVE NOT RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08006, Spain

ACTIVE NOT RECRUITING

Hospital Sant Pau i Sant Creu

Barcelona, 08025, Spain

ACTIVE NOT RECRUITING

Hospital de la Reina Sofia

Córdoba, 14004, Spain

NOT YET RECRUITING

Belfast City Hospital

Belfast, BT97AB, United Kingdom

NOT YET RECRUITING

Royal Sussex County Hospital

Brighton, United Kingdom

RECRUITING

St Thomas Hospital

London, SE1 7EH, United Kingdom

NOT YET RECRUITING

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

NOT YET RECRUITING

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

NOT YET RECRUITING

Related Publications (4)

  • 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.

    PMID: 40959874DERIVED

  • 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.

    PMID: 39907022DERIVED

  • 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.

    PMID: 36709485DERIVED

  • 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.

    PMID: 34002215DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • David Hildick-Smith, Dr

    Brighton and Sussex University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Tiago

CONTACT

+33176739258ptiago@cerc-europe.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 14, 2015

Study Start

February 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2020

Last Updated

March 8, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(3)SE(1)LA(1)DK(2)DE(2)ES(4)GB(5)FR(6)