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The European Bifurcation Club Left Main Study (EBC MAIN)

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ClinicalTrials.gov Identifier: NCT02497014
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
European Cardiovascular Research Center

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.

Condition or disease Intervention/treatment Phase
Percutaneous Transluminal Coronary Angioplasty Coronary Artery Disease Device: 1 Stent Device: 2 Stents Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: 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
Device: 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.

Experimental: 2 Stents
Patients who are going to receive 2 stents in both vessels
Device: 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.




Primary Outcome Measures :
  1. Composite of Death, Myocardial infarction and Target Lesion Revascularisation [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Death [ Time Frame: 1 year ]
  2. Myocardial Infarction [ Time Frame: 1 year ]
  3. Target Lesion Revascularization [ Time Frame: 1 year ]
  4. Angina status [ Time Frame: 1 year ]
  5. Stent thrombosis [ Time Frame: 1 year ]
  6. Death [ Time Frame: 3 years ]
  7. Myocardial Infarction [ Time Frame: 3 years ]
  8. Target Lesion Revascularization [ Time Frame: 3 years ]

Other Outcome Measures:
  1. Procedure success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time. [ Time Frame: up to 18 months ]
  2. Technical success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time. [ Time Frame: up to 18 months ]
  3. Number of procedural and in-hospital Major adverse Cardiac Events (MACE) [ Time Frame: up to 18 months ]
  4. Procedure duration [ Time Frame: intraoperative ]
  5. Fluoroscopy by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time [ Time Frame: up to 18 months ]
  6. X-ray dose [ Time Frame: up to 18 months ]
  7. Economic evaluation by assessing all procedural costs for each stenting strategy [ Time Frame: up to 18 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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
  • 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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497014


Contacts
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Contact: Patricia Tiago +33176739258 ptiago@cerc-europe.org

Locations
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Denmark
Aarhus University Hospital Active, not recruiting
Aarhus, Denmark, 8200
Rigshospitalet Copenhagen University Hospital Active, not recruiting
Copenhagen, Denmark, 2100
France
Clinique de Fontaine Not yet recruiting
Fontaine-lès-Dijon, France, 21121
Contact: Edda Calabro         
Principal Investigator: Philippe Brunel         
HCL CHU Luis Pradel Not yet recruiting
Lyon, France, 69500
Principal Investigator: Gérard Finet         
Hopital Jacques Cartier Not yet recruiting
Massy, France, 91300
Contact: Severine Roger         
Principal Investigator: Thomas Hovasse, Dr         
Clinique Saint Hilaire Not yet recruiting
Rouen, France, 76000
Contact: Françoise Hupel         
Principal Investigator: René Koning         
Clinique Pasteur Not yet recruiting
Toulouse, France, 31076
Contact: Frédéric Petit         
Principal Investigator: Jean Fajadet         
CHU Rangueil Not yet recruiting
Toulouse, France, 31403
Contact: Jacqueline Cahuzac    0033 5 61 32 33 45    Cahuzac.j@chu-toulouse.fr   
Contact: Ludovic Lacassagne    0033 5 61 32 33 45    Ludo.lacassagne@gmail.com   
Principal Investigator: Didier Carrié, Prof         
Germany
Herzzentrum Bad Krozingen Not yet recruiting
Bad Krozingen, Germany, 79189
Contact: Gudrun Dietsche    +49 76 33 402 5213    Gudrun.Dietsche@herzzentrum.de   
Contact: Johanna Korb    +49 7633 402 5211    ohanna.korb@herzzentrum.de   
Sub-Investigator: Miroslaw Ferenc, Dr med         
Elisabeth Krankenhaus Essen Recruiting
Essen, Germany, 45138
Contact: Vanessa Reuter         
Principal Investigator: Christoph Naber         
Italy
University of Catania - Ferrarotto Hospital Not yet recruiting
Catania, Italy, 95124
Contact: Laura Basile         
Principal Investigator: Corrado Tamburino         
Ospedale San Raffaele Not yet recruiting
Milano, Italy, 20132
Contact: Vega Rusconi         
Principal Investigator: Alaide Chieffo         
Universita Cattolica del Sacre Cuore Not yet recruiting
Roma, Italy, 00168
Principal Investigator: Francesco Burzotta         
Latvia
Pauls Stradins Clinical University Hospital Active, not recruiting
Riga, Latvia, 1002
Serbia
Clinical Center of Serbia Active, not recruiting
Belgrade, Serbia, 11000
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Paula Cabrero Cereto         
Principal Investigator: Beatriz Vaquerizo, Dr         
Hospital Clinic de Barcelona Active, not recruiting
Barcelona, Spain, 08006
Hospital Sant Pau i Sant Creu Active, not recruiting
Barcelona, Spain, 08025
Hospital de la Reina Sofia Not yet recruiting
Cordoba, Spain, 14004
Contact: Eva Cebrian         
Principal Investigator: Manuel Pan Alvarez Ossorio         
United Kingdom
Belfast City Hospital Not yet recruiting
Belfast, United Kingdom, BT97AB
Principal Investigator: Mark Spence         
Royal Sussex County Hospital Recruiting
Brighton, United Kingdom
Contact: Nicola Skipper         
Principal Investigator: David Hildick-Smith, David         
St Thomas Hospital Not yet recruiting
London, United Kingdom, SE1 7EH
Contact: Lucy Clack         
Principal Investigator: Simon Redwood, Dr         
Freeman Hospital Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Contact: Bijal Patel         
Principal Investigator: Mohaned Egred, Dr         
John Radcliffe Hospital Not yet recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Ellie Corps         
Principal Investigator: Adrian Banning         
Sponsors and Collaborators
European Cardiovascular Research Center
Medtronic
Investigators
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Principal Investigator: David Hildick-Smith, Dr Brighton and Sussex University Hospitals NHS Trust

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Responsible Party: European Cardiovascular Research Center
ClinicalTrials.gov Identifier: NCT02497014     History of Changes
Other Study ID Numbers: MED-03
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases