NCT04248777

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

January 28, 2020

Last Update Submit

January 29, 2020

Conditions

Left Main Coronary Artery Stenosis

Keywords

Optical Coherence Tomography (OCT)Percutaneous Coronary Intervention (PCI).

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • incidence of major adverse cardiovascular events

    30 days post PCI

  • rate of appropriate wire position

    30 days post PCI

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

    30 days post PCI

Study Arms (1)

left main PCI guided by OCT

OTHER

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

Other: standardised OCT-guided intervention

Interventions

standardised OCT-guided interventionOTHER

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.

left main PCI guided by OCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Chu Besancon

Besançon, 25030, France

Location

Chu Bordeaux

Bordeaux, 33000, France

Location

Clinique Saint Augustin

Bordeaux, 33200, France

Location

Hôpital privé Saint Martin

Caen, 14050, France

Location

Chu Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

Ch Chartres

Le Coudray, 28630, France

Location

Institut hospitalier Jacques Cartier

Massy, 91300, France

Location

Ch Annecy Genevois

Metz-Tessy, 74370, France

Location

CHU Nîmes

Nîmes, 30900, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Clinique Saint Hilaire

Rouen, 76000, France

Location

Study Officials

  • Nicolas AMABILE, MD,PhD

    Institut Mutualiste Montsouris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Patients with left main artery planned PCI for stable or unstable coronary artery disease.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

May 18, 2018

Primary Completion

January 28, 2019

Study Completion

February 1, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)