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Completed

NCT Number: NCT04248777

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

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).

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Key information

Conditions

Left Main Coronary Artery Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Besancon, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

standardised OCT-guided intervention

Other

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.

Primary outcomes

  1. success of the OCT procedure

    Time frame: Post PCI / Immediate

    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.

Secondary outcomes

  1. incidence of major adverse cardiovascular events

    Time frame: 30 days post PCI

    death, cardiovascular death, stent thrombosis, target vessel revascularization

  2. rate of appropriate wire position

    Time frame: 30 days post PCI

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

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

    Time frame: 30 days post PCI

    percentage of stent expansion according to DOCTORS and ILUMIEN-III

Sponsors and collaborators

Lead sponsor

Institut Mutualiste Montsouris

Other

Registry information

Official study title

LEft Main Oct Guided iNterventions

Acronym: LEMON

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2020
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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