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

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

Official Title
-----------------
LEft Main Oct Guided iNterventions

Conditions
-----------------
Left Main Coronary Artery Stenosis

Intervention / Treatment
-----------------
* Other: standardised OCT-guided intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with left main artery planned PCI for stable or unstable coronary artery disease.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: left main PCI guided by OCT<br>The LM PCI strategy is guided by 3 OCT runs, according to a pre-defined standardized protocol. | Other: standardised OCT-guided intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post PCI / Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of major adverse cardiovascular events | death, cardiovascular death, stent thrombosis, target vessel revascularization | 30 days post PCI | 
| rate of appropriate wire position | percentage of appropriate wire position in adequate stent cell before side branch ostium dilation. | 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 | 30 days post PCI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI).