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The European Bifurcation Club Left Main Study

The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02497014
Acronym
EBC MAIN
Enrollment
450
Registered
2015-07-14
Start date
2016-02-29
Completion date
2020-08-31
Last updated
2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Percutaneous Transluminal Coronary Angioplasty

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.

Interventions

DEVICE1 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.

DEVICE2 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.

Sponsors

Medtronic
CollaboratorINDUSTRY
European Cardiovascular Research Center
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Composite of Death, Myocardial infarction and Target Lesion Revascularisation1 year

Secondary

MeasureTime frame
Death1 year
Myocardial Infarction1 year
Target Lesion Revascularization1 year
Angina status1 year
Stent thrombosis1 year

Other

MeasureTime 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
Economic evaluation by assessing all procedural costs for each stenting strategyup 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
Procedure durationintraoperative
Fluoroscopy by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural timeup to 18 months
X-ray doseup to 18 months

Countries

Denmark, France, Germany, Italy, Latvia, Serbia, Spain, United Kingdom

Contacts

Primary ContactPatricia Tiago
ptiago@cerc-europe.org+33176739258

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026