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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-18

Study Completion Date

2019-02-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Left Main Coronary Artery Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients with left main artery planned PCI for stable or unstable coronary artery disease.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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left main PCI guided by OCT

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

Group Type OTHER

standardised OCT-guided intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No