The European Bifurcation Club Left Main Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Disease

Intervention / Treatment
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* Device: 1 Stent
* Device: 2 Stents


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Stent<br>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<br>* 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.<br>|
| Experimental: 2 Stents<br>Patients who are going to receive 2 stents in both vessels | Device: 2 Stents<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Death, Myocardial infarction and Target Lesion Revascularisation |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 1 year | 
| Myocardial Infarction |  | 1 year | 
| Target Lesion Revascularization |  | 1 year | 
| Angina status |  | 1 year | 
| Stent thrombosis |  | 1 year | 
| Death |  | 3 years | 
| Myocardial Infarction |  | 3 years | 
| Target Lesion Revascularization |  | 3 years |