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

Primary Purpose

Left Main Coronary Artery Stenosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
standardised OCT-guided intervention
Sponsored by
Institut Mutualiste Montsouris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Left Main Coronary Artery Stenosis focused on measuring Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI).

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Chu Besancon
  • Chu Bordeaux
  • Clinique Saint Augustin
  • Hôpital privé Saint Martin
  • Chu Clermont Ferrand
  • Ch Chartres
  • Institut hospitalier Jacques Cartier
  • Ch Annecy Genevois
  • CHU Nîmes
  • Institut Mutualiste Montsouris
  • Clinique Saint Hilaire

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

left main PCI guided by OCT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

incidence of major adverse cardiovascular events
death, cardiovascular death, stent thrombosis, target vessel revascularization
rate of appropriate wire position
percentage of appropriate wire position in adequate stent cell before side branch ostium dilation.
rate of appropriate stent expansion according to DOCTORS and ILUMIEN-III criteria.
percentage of stent expansion according to DOCTORS and ILUMIEN-III

Full Information

First Posted
January 28, 2020
Last Updated
January 29, 2020
Sponsor
Institut Mutualiste Montsouris
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1. Study Identification

Unique Protocol Identification Number
NCT04248777
Brief Title
Optical Coherence Tomography - Guided Protocol for Left Main Percutaneous Coronary Intervention
Acronym
LEMON
Official Title
LEft Main Oct Guided iNterventions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
January 28, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Mutualiste Montsouris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Main Coronary Artery Stenosis
Keywords
Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI).

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with left main artery planned PCI for stable or unstable coronary artery disease.
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
left main PCI guided by OCT
Arm Type
Other
Arm Description
The LM PCI strategy is guided by 3 OCT runs, according to a pre-defined standardized protocol.
Intervention Type
Other
Intervention Name(s)
standardised OCT-guided intervention
Intervention Description
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 Outcome Measure Information:
Title
success of the OCT procedure
Description
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 Outcome Measure Information:
Title
incidence of major adverse cardiovascular events
Description
death, cardiovascular death, stent thrombosis, target vessel revascularization
Time Frame
30 days post PCI
Title
rate of appropriate wire position
Description
percentage of appropriate wire position in adequate stent cell before side branch ostium dilation.
Time Frame
30 days post PCI
Title
rate of appropriate stent expansion according to DOCTORS and ILUMIEN-III criteria.
Description
percentage of stent expansion according to DOCTORS and ILUMIEN-III
Time Frame
30 days post PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas AMABILE, MD,PhD
Organizational Affiliation
Institut Mutualiste Montsouris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Besancon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Chu Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Clinique Saint Augustin
City
Bordeaux
ZIP/Postal Code
33200
Country
France
Facility Name
Hôpital privé Saint Martin
City
Caen
ZIP/Postal Code
14050
Country
France
Facility Name
Chu Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Ch Chartres
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
Institut hospitalier Jacques Cartier
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Ch Annecy Genevois
City
Metz-Tessy
ZIP/Postal Code
74370
Country
France
Facility Name
CHU Nîmes
City
Nîmes
ZIP/Postal Code
30900
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Clinique Saint Hilaire
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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