Optical Coherence Tomography - Guided Protocol for Left Main Percutaneous Coronary Intervention

Institut Mutualiste Montsouris71 enrolled

Overview

LEMON aim is to evaluate the feasibility, efficiency and security of a standardized Optical Coherence Tomography (OCT) - guided protocol for completion and optimization of Left Main (LM) Percutaneous Coronary Intervention (PCI).

The LEMON study (LEft Main Oct-guided iNterventions) is a prospective, multicentre, open-label, interventional , non-randomized trial that investigates the feasibility and efficiency of OCT guidance for left main PCI in 10 active French interventional cardiology centres. The aim of the study is the appliance of a pre-defined standardized protocol for LM PCI . The LM PCI strategy is guided by 3 OCT runs, according to a pre-determined protocol. The first OCT run (run1) is performed before any stent implantation, the second run (run2) is performed after the stent is implanted, POT (proximal optimization technique) is applied and side branch iss rewired through stent struts. The third run (run3) is performed after PCI optimization. In case of additional stent optimization, a supplementary OCT run is applied in order to assess final result.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Left Main Coronary Artery Stenosis

Interventions

standardised OCT-guided interventionOTHER

The first OCT run (run1) analyse plaque characteristics, identify proximal and distal landing zones (according to previously published criteria) , measure lesion length and reference segments dimensions (diameters and luminal areas). The second run (run2) aims to assess adequate guidewire recrossing point into stent jailed side branch and identify early stent mechanical non-optimal results. The third run (run3) analyse final stent expansion and identify major struts malposition and edge dissection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \>18 * stable or non-stable distal Left Main lesion (with or without previous Coronary Artery Bypass Graft), involving or not Left Anterior Descending and Coronary Circumflex ostias and requiring Percutaneous Coronary Intervention with a one or two stents strategy * stable or non-stable ostial Left Anterior Descending and/or Coronary Circumflex lesion requiring Percutaneous Coronary Intervention with involvement of distal Left Main * SYNTAX angiographic score \<23 * informed consent Exclusion Criteria: * ostial Left Main lesion * on-going acute STEMI * on-going cardiogenic shock * severe chronic renal failure (Cr Cl \<30 ml/min/m2) * anticipated technical contra-indication to OCT (highly calcified lesions, severe proximal tortuosity)

Locations (11)

Chu Besancon

Besançon, France

Chu Bordeaux

Bordeaux, France

Clinique Saint Augustin

Bordeaux, France

Hôpital privé Saint Martin

Caen, France

Outcomes

Primary Outcomes

success of the OCT procedure

score Thrombolysis In Myocardial Infarction (TIMI) equal to 3 in all vessels, 50% residual stenosis in the various angiography segments, adequate expansion according to minimum intra stent area \> 80% of the luminal area of the reference segment on Main Vessel and Main Branch.

Time frame: Post PCI / Immediate

Secondary Outcomes

incidence of major adverse cardiovascular events

death, cardiovascular death, stent thrombosis, target vessel revascularization

Time frame: 30 days post PCI

rate of appropriate wire position

percentage of appropriate wire position in adequate stent cell before side branch ostium dilation.

Time frame: 30 days post PCI

rate of appropriate stent expansion according to DOCTORS and ILUMIEN-III criteria.

percentage of stent expansion according to DOCTORS and ILUMIEN-III

Time frame: 30 days post PCI

Data from ClinicalTrials.gov

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