The European Bifurcation Club Left Main Study (EBC MAIN)

March 7, 2016 updated by: European Cardiovascular Research Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Active, not recruiting
        • Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Active, not recruiting
        • Rigshospitalet Copenhagen University Hospital
  • France
      • Fontaine-lès-Dijon, France, 21121
        • Not yet recruiting
        • Clinique de Fontaine
        • Contact:
          • Edda Calabro
        • Principal Investigator:
          • Philippe Brunel
      • Lyon, France, 69500
        • Not yet recruiting
        • HCL CHU Luis Pradel
        • Principal Investigator:
          • Gérard Finet
      • Massy, France, 91300
        • Not yet recruiting
        • Hopital Jacques Cartier
        • Contact:
          • Severine Roger
        • Principal Investigator:
          • Thomas Hovasse, Dr
      • Rouen, France, 76000
        • Not yet recruiting
        • Clinique Saint Hilaire
        • Contact:
          • Françoise Hupel
        • Principal Investigator:
          • René Koning
      • Toulouse, France, 31076
        • Not yet recruiting
        • Clinique Pasteur
        • Principal Investigator:
          • Jean Fajadet
        • Contact:
          • Frédéric Petit
      • Toulouse, France, 31403
        • Not yet recruiting
        • CHU Rangueil
        • Contact:
        • Contact:
        • Principal Investigator:
          • Didier Carrié, Prof
  • Germany
      • Bad Krozingen, Germany, 79189
      • Essen, Germany, 45138
        • Recruiting
        • Elisabeth Krankenhaus Essen
        • Contact:
          • Vanessa Reuter
        • Principal Investigator:
          • Christoph Naber
  • Italy
      • Catania, Italy, 95124
        • Not yet recruiting
        • University of Catania - Ferrarotto Hospital
        • Principal Investigator:
          • Corrado Tamburino
        • Contact:
          • Laura Basile
      • Milano, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele
        • Contact:
          • Vega Rusconi
        • Principal Investigator:
          • Alaide Chieffo
      • Roma, Italy, 00168
        • Not yet recruiting
        • Universita Cattolica del Sacre Cuore
        • Principal Investigator:
          • Francesco Burzotta
  • Latvia
      • Riga, Latvia, 1002
        • Active, not recruiting
        • Pauls Stradins Clinical University Hospital
  • Serbia
      • Belgrade, Serbia, 11000
        • Active, not recruiting
        • Clinical Center of Serbia
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Contact:
          • Paula Cabrero Cereto
        • Principal Investigator:
          • Beatriz Vaquerizo, Dr
      • Barcelona, Spain, 08006
        • Active, not recruiting
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08025
        • Active, not recruiting
        • Hospital Sant Pau i Sant Creu
      • Cordoba, Spain, 14004
        • Not yet recruiting
        • Hospital de la Reina Sofia
        • Contact:
          • Eva Cebrian
        • Principal Investigator:
          • Manuel Pan Alvarez Ossorio
  • United Kingdom
      • Belfast, United Kingdom, BT97AB
        • Not yet recruiting
        • Belfast City Hospital
        • Principal Investigator:
          • Mark Spence
      • Brighton, United Kingdom
        • Recruiting
        • Royal Sussex County Hospital
        • Contact:
          • Nicola Skipper
        • Principal Investigator:
          • David Hildick-Smith, David
      • London, United Kingdom, SE1 7EH
        • Not yet recruiting
        • St Thomas Hospital
        • Contact:
          • Lucy Clack
        • Principal Investigator:
          • Simon Redwood, Dr
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Not yet recruiting
        • Freeman Hospital
        • Contact:
          • Bijal Patel
        • Principal Investigator:
          • Mohaned Egred, Dr
      • Oxford, United Kingdom, OX3 9DU
        • Not yet recruiting
        • John Radcliffe Hospital
        • Principal Investigator:
          • Adrian Banning
        • Contact:
          • Ellie Corps

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite of Death, Myocardial infarction and Target Lesion Revascularisation
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Death
Time Frame: 3 years
3 years
Death
Time Frame: 1 year
1 year
Stent thrombosis
Time Frame: 1 year
1 year
Myocardial Infarction
Time Frame: 1 year
1 year
Target Lesion Revascularization
Time Frame: 1 year
1 year
Angina status
Time Frame: 1 year
1 year
Myocardial Infarction
Time Frame: 3 years
3 years
Target Lesion Revascularization
Time Frame: 3 years
3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Procedure duration
Time Frame: intraoperative
intraoperative
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
up to 18 months
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
up to 18 months
Number of procedural and in-hospital Major adverse Cardiac Events (MACE)
Time Frame: up to 18 months
up to 18 months
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
up to 18 months
X-ray dose
Time Frame: up to 18 months
up to 18 months
Economic evaluation by assessing all procedural costs for each stenting strategy
Time Frame: up to 18 months
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Cardiovascular Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Hildick-Smith, Dr, Brighton and Sussex University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MED-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on 1 Stent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings