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

LEft Main Oct Guided iNterventions

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).

Study Overview

• Status: Completed
• Conditions: Left Main Coronary Artery Stenosis
• Intervention / Treatment: Other: standardised OCT-guided intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25030
    • CHU Besançon
  • Bordeaux, France, 33000
    • CHU Bordeaux
  • Bordeaux, France, 33200
    • Clinique Saint Augustin
  • Caen, France, 14050
    • Hôpital Privé saint Martin
  • Clermont Ferrand, France, 63000
    • CHU Clermont Ferrand
  • Le Coudray, France, 28630
    • CH Chartres
  • Massy, France, 91300
    • Institut Hospitalier Jacques Cartier
  • Metz-Tessy, France, 74370
    • Ch Annecy Genevois
  • Nîmes, France, 30900
    • CHU Nîmes
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Rouen, France, 76000
    • Clinique Saint Hilaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: left main PCI guided by OCT; The LM PCI strategy is guided by 3 OCT runs, according to a pre-defined standardized protocol.

Other: standardised OCT-guided intervention; 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.

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

Collaborators and Investigators

• Sponsor: Institut Mutualiste Montsouris
• Investigators: Principal Investigator: Nicolas AMABILE, MD,PhD, Institut Mutualiste Montsouris

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 18, 2018
• Primary Completion (ACTUAL): January 28, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (ACTUAL): January 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography (OCT); Percutaneous Coronary Intervention (PCI).
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: CARDIO-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No