The European Bifurcation Club Left Main Study (EBC MAIN)

European Cardiovascular Research Institute (ECRI)

Status: Unknown

Conditions: Coronary Artery Disease; Percutaneous Transluminal Coronary Angioplasty

Treatments: Device: 1 Stent; Device: 2 Stents

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02497014

MED-03

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

1 Stent

Experimental group

Description:

Patients who are going to receive 1 stent in the main vessel and the side vessel will be treated with kissing ballon inflation

Treatment:

Device: 1 Stent

2 Stents

Experimental group

Description:

Patients who are going to receive 2 stents in both vessels

Treatment:

Device: 2 Stents